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Article ; Online: Changes in activity impairment and work productivity after treatment for vitreous hemorrhage due to proliferative diabetic retinopathy: Secondary outcomes from a randomized controlled trial (DRCR Retina Network Protocol AB).

Beaulieu, Wesley T / Maguire, Maureen G / Antoszyk, Andrew N

2023 Volume 18, Issue 11, Page(s) e0293543

Abstract: Background: Vitreous hemorrhage from proliferative diabetic retinopathy can cause severe vision loss. DRCR Retina Network Protocol AB was a randomized clinical trial comparing intravitreal aflibercept versus vitrectomy with panretinal photocoagulation ... ...

Abstract	Background: Vitreous hemorrhage from proliferative diabetic retinopathy can cause severe vision loss. DRCR Retina Network Protocol AB was a randomized clinical trial comparing intravitreal aflibercept versus vitrectomy with panretinal photocoagulation and found no difference in the average rate of visual recovery over 104 weeks. Herein, we describe patient-reported outcome measures from Protocol AB. Methods: Secondary analysis of a multicenter (39 sites) randomized clinical trial. The Work Productivity and Activity Impairment Questionnaire was administered at 4, 12, 24, 36, 52, 68, 84, and 104 weeks. Main outcomes were mean change in activity impairment and work productivity loss over 24 and 104 weeks (area under the curve). Results: Mean (SD) activity impairment at baseline was 58% (27%) in the aflibercept group (N = 99) and 56% (30%) in the vitrectomy group (N = 105). The mean reduction in activity impairment from baseline over 24 weeks was 21% (25%) in the aflibercept group and 27% (31%) in the vitrectomy group (adjusted difference = -6.8% [95% CI, -12.7% to -0.9%], P = .02); over 104 weeks, the adjusted mean difference was -3.1% (95% CI, -9.2% to 3.0%, P = .31). Mean work productivity loss at baseline was 51% (28%) in the aflibercept group (N = 44) and 58% (30%) in the vitrectomy group (N = 43). The mean reduction in work productivity loss from baseline over 24 weeks (area under the curve) was 19% (23%) in the aflibercept group and 31% (24%) in the vitrectomy group (adjusted difference = -8.3% [95% CI, -16.8% to 0.2%], P = .06); over 104 weeks, the adjusted mean difference was -9.1% (95% CI, -18.4% to 0.2%, P = .05). Conclusions: Participants with vitreous hemorrhage from proliferative diabetic retinopathy had less activity impairment over 24 weeks when treated initially with vitrectomy and panretinal photocoagulation versus intravitreal aflibercept. The trend was similar for work productivity but not statistically significant. By 104 weeks, the improvements were similar in the two treatment groups. Trial registration: ClinicalTrials.gov NCT02858076.
MeSH term(s)	Humans ; Angiogenesis Inhibitors/therapeutic use ; Diabetes Mellitus/drug therapy ; Diabetic Retinopathy/therapy ; Diabetic Retinopathy/drug therapy ; Intravitreal Injections ; Retina ; Visual Acuity ; Vitreous Hemorrhage/etiology ; Vitreous Hemorrhage/surgery
Chemical Substances	Angiogenesis Inhibitors
Language	English
Publishing date	2023-11-16
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0293543
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: "Pacman" invasion of the retina: Two cases of ophthalmomyiasis interna posterior.

Punjabi, Omar S / Browning, David J / Clark, Loraine / Antoszyk, Andrew N

American journal of ophthalmology case reports

2019 Volume 15, Page(s) 100491

Abstract: Purpose: To discuss two striking cases of ophthalmomyiasis interna posterior, in which the larval stage of a botfly is found in the posterior segment.: Observations: In the first case, the subretinal maggot is alive and found to be migrating under ... ...

Abstract	Purpose: To discuss two striking cases of ophthalmomyiasis interna posterior, in which the larval stage of a botfly is found in the posterior segment. Observations: In the first case, the subretinal maggot is alive and found to be migrating under the retina. The maggot was lasered in the office and killed. In the second case, a dead maggot was discovered in the subretinal space in a child, after it had caused significant subretinal scarring and permanent vision loss. Conclusions and importance: Ophthalmomyiasis is a rare condition that can often be unrecognized and result in permanent vision loss. Early diagnosis and photocoagulation of the larva (if alive) can halt progression of vision loss in these cases.
Language	English
Publishing date	2019-06-06
Publishing country	United States
Document type	Case Reports
ISSN	2451-9936
ISSN (online)	2451-9936
DOI	10.1016/j.ajoc.2019.100491
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Article ; Online: Ranibizumab in Diabetic Retinopathy with or without Diabetic Macular Edema.

Antoszyk, Andrew N / Tarnowski, Kathleen Wade / Basu, Karen / Ehrlich, Jason S / Haskova, Zdenka

Ophthalmology. Retina

2020 Volume 4, Issue 10, Page(s) 1034–1036

MeSH term(s)	Angiogenesis Inhibitors/administration & dosage ; Diabetic Retinopathy/complications ; Diabetic Retinopathy/diagnosis ; Diabetic Retinopathy/drug therapy ; Humans ; Intravitreal Injections ; Macular Edema/diagnosis ; Macular Edema/drug therapy ; Macular Edema/etiology ; Ranibizumab/administration & dosage ; Tomography, Optical Coherence/methods ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity
Chemical Substances	Angiogenesis Inhibitors ; Vascular Endothelial Growth Factor A ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2020-06-05
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ISSN	2468-6530
ISSN (online)	2468-6530
DOI	10.1016/j.oret.2020.05.020
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Article ; Online: Visual Acuity Outcomes after Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study 2 Report Number 19.

Keenan, Tiarnan D / Vitale, Susan / Agrón, Elvira / Domalpally, Amitha / Antoszyk, Andrew N / Elman, Michael J / Clemons, Traci E / Chew, Emily Y

Ophthalmology. Retina

2019 Volume 4, Issue 1, Page(s) 3–12

Abstract: Purpose: To analyze best-corrected visual acuity (BCVA) outcomes after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD).: Design: Prospective cohort study of participants enrolled in a ... ...

Abstract	Purpose: To analyze best-corrected visual acuity (BCVA) outcomes after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD). Design: Prospective cohort study of participants enrolled in a clinical trial of oral supplements and receiving anti-VEGF therapy in routine clinical practice. Participants: Age-Related Eye Disease Study 2 (AREDS2) participants (50-85 years of age) whose eyes met AREDS2 inclusion criteria at baseline (no late AMD, BCVA ≥20/100, no previous anti-VEGF injections) but received at least 1 anti-VEGF injection for incident neovascular AMD during follow-up. Methods: Participants underwent refracted BCVA testing, ophthalmoscopic examination, and stereoscopic color fundus photography at baseline and annual study visits over 5 years. Self-reports of anti-VEGF injections (numbers, dates, and names of drug) were collected at baseline and annual study visits and during telephone calls every 6 months. Main outcome measures: Primary outcome measures were mean refracted BCVA and proportions of eyes with BCVA of 20/40 or better and 20/200 or worse. An exploratory outcome measure was the mean number of self-reported anti-VEGF injections. Results: One thousand one hundred five eyes of 986 AREDS2 participants met the inclusion criteria; of these, 977 participants (99.1%) underwent at least 1 posttreatment visit. At the first and subsequent annual examinations after the first injection, mean refracted BCVAs were 68.0 letters (Snellen equivalent, 20/40), 66.1 letters, 64.7 letters, 63.2 letters, and 61.5 letters (Snellen equivalent, 20/60). Proportions of eyes with BCVA of 20/40 or better were 59.3%, 55.1%, 53.5%, 50.6%, and 49.7%, and those with BCVA of 20/200 or worse were 5.5%, 8.6%, 9.4%, 12.4%, and 14.4%. Mean annual numbers of self-reported anti-VEGF injections per eye were 2.9, 3.9, 3.3, 3.1, and 3.0. Conclusions: Refracted BCVA data were obtained in a clinical trial environment but were related to anti-VEGF treatment administered in normal clinical practice. Visual outcomes declined slowly with increased follow-up time: mean BCVA decreased by approximately 1.5 to 2 letters per year. At 5 years, half of eyes achieved BCVA of 20/40 or better, but approximately one sixth showed BCVA of 20/200 or worse. These data may be useful in assessing the long-term effects of anti-VEGF therapy.
MeSH term(s)	Aged ; Aged, 80 and over ; Angiogenesis Inhibitors/therapeutic use ; Choroidal Neovascularization/drug therapy ; Choroidal Neovascularization/physiopathology ; Docosahexaenoic Acids/administration & dosage ; Double-Blind Method ; Drug Combinations ; Eicosapentaenoic Acid/administration & dosage ; Female ; Follow-Up Studies ; Humans ; Intravitreal Injections ; Lutein/administration & dosage ; Male ; Middle Aged ; Prospective Studies ; Surveys and Questionnaires ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/physiology ; Wet Macular Degeneration/drug therapy ; Wet Macular Degeneration/physiopathology ; Zeaxanthins/administration & dosage
Chemical Substances	Angiogenesis Inhibitors ; Drug Combinations ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; Zeaxanthins ; Docosahexaenoic Acids (25167-62-8) ; Eicosapentaenoic Acid (AAN7QOV9EA) ; Lutein (X72A60C9MT)
Language	English
Publishing date	2019-06-11
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2468-6530
ISSN (online)	2468-6530
DOI	10.1016/j.oret.2019.06.001
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Article ; Online: Effect of Intravitreous Anti-Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial.

Maturi, Raj K / Glassman, Adam R / Josic, Kristin / Antoszyk, Andrew N / Blodi, Barbara A / Jampol, Lee M / Marcus, Dennis M / Martin, Daniel F / Melia, Michele / Salehi-Had, Hani / Stockdale, Cynthia R / Punjabi, Omar S / Sun, Jennifer K

JAMA ophthalmology

2021 Volume 139, Issue 7, Page(s) 701–712

Abstract: Importance: The role of anti-vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established.: Objective: To ... ...

Abstract	Importance: The role of anti-vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established. Objective: To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. Design, setting, and participants: Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME. Analyses followed the intent-to-treat principle. Interventions: Eyes were randomly assigned to 2.0 mg of aflibercept injections (n = 200) or sham (n = 199) given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed. Main outcomes and measures: Development of CI-DME with vision loss or PDR through May 2020, when the last 2-year visit was completed. Results: Among the 328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years), the 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs 43.5% with sham. The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs 33.2% in the sham group, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs 14.8% in the sham group. The mean (SD) change in visual acuity from baseline to 2 years was -0.9 (5.8) letters with aflibercept and -2.0 (6.1) letters with sham (adjusted mean difference, 0.5 letters [97.5% CI, -1.0 to 1.9 letters]; P = .47). Conclusions and relevance: In this randomized clinical trial, among eyes with moderate to severe NPDR, the proportion of eyes that developed PDR or vision-reducing CI-DME was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME. The 4-year results will be important to assess longer-term visual acuity outcomes. Trial registration: ClinicalTrials.gov Identifier: NCT02634333.
MeSH term(s)	Adult ; Angiogenesis Inhibitors/therapeutic use ; Canada ; Diabetes Mellitus/drug therapy ; Diabetic Retinopathy/complications ; Diabetic Retinopathy/diagnosis ; Diabetic Retinopathy/drug therapy ; Female ; Humans ; Intravitreal Injections ; Macular Edema/drug therapy ; Macular Edema/etiology ; Macular Edema/prevention & control ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Ranibizumab/therapeutic use ; Vascular Endothelial Growth Factor A
Chemical Substances	Angiogenesis Inhibitors ; Vascular Endothelial Growth Factor A ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2021-03-30
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2701705-9
ISSN	2168-6173 ; 2168-6165
ISSN (online)	2168-6173
ISSN	2168-6165
DOI	10.1001/jamaophthalmol.2021.0606
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Article ; Online: Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.

Glassman, Adam R / Beaulieu, Wesley T / Maguire, Maureen G / Antoszyk, Andrew N / Chow, Clement C / Elman, Michael J / Jampol, Lee M / Salehi-Had, Hani / Sun, Jennifer K

JAMA ophthalmology

2021 Volume 139, Issue 7, Page(s) 725–733

Abstract: Importance: Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative ... ...

Abstract	Importance: Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices. Objective: To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. Design, setting, and participants: This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020. Interventions: Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria. Main outcomes and measures: Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. Results: A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57 [11] years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001). Conclusions and relevance: Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage. Trial registration: ClinicalTrials.gov Identifier: NCT02858076.
MeSH term(s)	Angiogenesis Inhibitors ; Diabetes Mellitus/drug therapy ; Diabetic Retinopathy/complications ; Diabetic Retinopathy/diagnosis ; Diabetic Retinopathy/drug therapy ; Female ; Humans ; Intravitreal Injections ; Male ; Middle Aged ; Ranibizumab/therapeutic use ; Receptors, Vascular Endothelial Growth Factor ; Recombinant Fusion Proteins ; Treatment Outcome ; Vascular Endothelial Growth Factor A ; Visual Acuity ; Vitrectomy ; Vitreous Hemorrhage/diagnosis ; Vitreous Hemorrhage/drug therapy ; Vitreous Hemorrhage/etiology
Chemical Substances	Angiogenesis Inhibitors ; Recombinant Fusion Proteins ; Vascular Endothelial Growth Factor A ; aflibercept (15C2VL427D) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2021-05-06
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2701705-9
ISSN	2168-6173 ; 2168-6165
ISSN (online)	2168-6173
ISSN	2168-6165
DOI	10.1001/jamaophthalmol.2021.1110
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Article ; Online: Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies to Evaluate Critical Task Completion by Healthcare Professionals.

Antoszyk, Andrew N / Baker, Carl / Calzada, Jorge / Cummings, Howard / So, Joanna / Quezada-Ruiz, Carlos / Haskova, Zdenka

PDA journal of pharmaceutical science and technology

2018 Volume 72, Issue 4, Page(s) 411–419

Abstract: Purpose: A ranibizumab prefilled syringe (PFS) has been approved by the U.S. Food and Drug Administration. Here we evaluate the use of the ranibizumab PFS for intravitreal injection by assessing whether the PFS enables healthcare providers to ... ...

Abstract	Purpose: A ranibizumab prefilled syringe (PFS) has been approved by the U.S. Food and Drug Administration. Here we evaluate the use of the ranibizumab PFS for intravitreal injection by assessing whether the PFS enables healthcare providers to successfully prepare and administer an injection without prior training. Design: Simulated-use and actual-use human factors usability studies. Participants: Retina specialists and ophthalmic medical personnel. Methods: In a simulated-use summative usability study, retina specialists (n = 15) and ophthalmic medical personnel (n = 15) prepared the ranibizumab PFS and performed injections into a model eye. In an actual-use formative usability study (ClinicalTrials.gov identifier: NCT02698566), three assistants and three retina specialists prepared the PFS and performed intravitreal injections, respectively, in study eyes of patients with retinal diseases (n = 35). Main outcome measures: Twelve tasks specific to the unpacking, preparing, and properly administering the PFS for intravitreal injection were evaluated by a study assessor. Task performances were evaluated for use errors, close calls, and operational difficulties. Post-injection subjective user evaluations were performed to assess ease of use. Results: All participants successfully performed all essential and safety-critical tasks without use error in both the simulated-use and actual-use human factors usability studies. The majority of participants rated the tasks required to use the ranibizumab PFS as "Easy" or "Very Easy." Conclusions: Both the simulated-use and actual-use usability studies yielded consistent data, showing that healthcare professionals are able to use the ranibizumab PFS by successfully performing all critical tasks involved in preparing and delivering an intravitreal injection. The simulated-use usability testing was sufficiently realistic and representative of real-world use, and was appropriate and preferred over actual-use usability testing for proper evaluation of the product user interface.
MeSH term(s)	Angiogenesis Inhibitors/administration & dosage ; Computer Simulation ; Health Personnel ; Humans ; Intravitreal Injections ; Medication Errors ; Ranibizumab/administration & dosage ; Retinal Diseases/drug therapy ; Syringes
Chemical Substances	Angiogenesis Inhibitors ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2018-05-31
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1205009-x
ISSN	1948-2124 ; 0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
ISSN (online)	1948-2124
ISSN	0277-3406 ; 1076-397X ; 0279-7976 ; 1079-7440
DOI	10.5731/pdajpst.2017.008342
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Article ; Online: Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).

Glassman, Adam R / Wells, John A / Josic, Kristin / Maguire, Maureen G / Antoszyk, Andrew N / Baker, Carl / Beaulieu, Wesley T / Elman, Michael J / Jampol, Lee M / Sun, Jennifer K

Ophthalmology

2020 Volume 127, Issue 9, Page(s) 1201–1210

Abstract: Purpose: Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.: Design: Multicenter cohort study.: ... ...

Abstract	Purpose: Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial. Design: Multicenter cohort study. Participants: Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion). Methods: Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit. Main outcome measures: Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST). Results: Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9). Conclusions: Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.
MeSH term(s)	Aged ; Angiogenesis Inhibitors/therapeutic use ; Bevacizumab/therapeutic use ; Cohort Studies ; Diabetic Retinopathy/drug therapy ; Diabetic Retinopathy/physiopathology ; Female ; Follow-Up Studies ; Humans ; Intravitreal Injections ; Laser Coagulation ; Macular Edema/drug therapy ; Macular Edema/physiopathology ; Male ; Middle Aged ; Ranibizumab/therapeutic use ; Receptors, Vascular Endothelial Growth Factor/therapeutic use ; Recombinant Fusion Proteins/therapeutic use ; Tomography, Optical Coherence ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/physiology
Chemical Substances	Angiogenesis Inhibitors ; Recombinant Fusion Proteins ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; aflibercept (15C2VL427D) ; Bevacizumab (2S9ZZM9Q9V) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Ranibizumab (ZL1R02VT79)
Language	English
Publishing date	2020-03-29
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	392083-5
ISSN	1549-4713 ; 0161-6420
ISSN (online)	1549-4713
ISSN	0161-6420
DOI	10.1016/j.ophtha.2020.03.021
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Article ; Online: Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.

Antoszyk, Andrew N / Glassman, Adam R / Beaulieu, Wesley T / Jampol, Lee M / Jhaveri, Chirag D / Punjabi, Omar S / Salehi-Had, Hani / Wells, John A / Maguire, Maureen G / Stockdale, Cynthia R / Martin, Daniel F / Sun, Jennifer K

JAMA

2020 Volume 324, Issue 23, Page(s) 2383–2395

Abstract: Importance: Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.: Objective: To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal ... ...

Abstract	Importance: Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown. Objective: To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. Design, setting, and participants: Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020. Interventions: Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. Main outcomes and measures: The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. Results: Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept. Conclusions and relevance: Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. Trial registration: ClinicalTrials.gov Identifier: NCT02858076.
MeSH term(s)	Aged ; Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Cataract Extraction ; Confidence Intervals ; Diabetic Retinopathy/complications ; Female ; Humans ; Intravitreal Injections ; Light Coagulation ; Male ; Middle Aged ; Postoperative Complications ; Receptors, Vascular Endothelial Growth Factor/administration & dosage ; Recombinant Fusion Proteins/administration & dosage ; Recombinant Fusion Proteins/adverse effects ; Retina/surgery ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity ; Vitrectomy/adverse effects ; Vitreous Hemorrhage/drug therapy ; Vitreous Hemorrhage/etiology ; Vitreous Hemorrhage/surgery
Chemical Substances	Angiogenesis Inhibitors ; Recombinant Fusion Proteins ; Vascular Endothelial Growth Factor A ; aflibercept (15C2VL427D) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1)
Language	English
Publishing date	2020-12-14
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2020.23027
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Article ; Online: EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT: Results of the OASIS Trial ERG Substudy.

Birch, David G / Benz, Matthew S / Miller, Daniel M / Antoszyk, Andrew N / Markoff, Joseph / Kozma, Petra / Meunier, Esmeralda / Sergott, Robert C

Retina (Philadelphia, Pa.)

2017

Abstract: Purpose: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for ...

Abstract	Purpose: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin. Methods: The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28. Results: In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions. Conclusion: Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Language	English
Publishing date	2017-02-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	603192-4
ISSN	1539-2864 ; 0275-004X
ISSN (online)	1539-2864
ISSN	0275-004X
DOI	10.1097/IAE.0000000000001536
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