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  1. Article ; Online: Dexamethasone and Anti-VEGF Combination Therapy for the Treatment of Diabetic Macular Edema.

    Al-Khersan, Hasenin / Hariprasad, Seenu M / Salehi-Had, Hani

    Ophthalmic surgery, lasers & imaging retina

    2019  Volume 50, Issue 1, Page(s) 4–7

    MeSH term(s) Angiogenesis Inhibitors/administration & dosage ; Bevacizumab/administration & dosage ; Dexamethasone/administration & dosage ; Diabetic Retinopathy/complications ; Diabetic Retinopathy/drug therapy ; Dose-Response Relationship, Drug ; Drug Implants ; Drug Therapy, Combination ; Glucocorticoids/administration & dosage ; Humans ; Intravitreal Injections ; Macular Edema/drug therapy ; Macular Edema/etiology ; Treatment Outcome ; Vascular Endothelial Growth Factor A/antagonists & inhibitors
    Chemical Substances Angiogenesis Inhibitors ; Drug Implants ; Glucocorticoids ; Vascular Endothelial Growth Factor A ; Bevacizumab (2S9ZZM9Q9V) ; Dexamethasone (7S5I7G3JQL)
    Language English
    Publishing date 2019-01-08
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2701167-7
    ISSN 2325-8179 ; 2325-8160
    ISSN (online) 2325-8179
    ISSN 2325-8160
    DOI 10.3928/23258160-20181212-01
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Four-Year Visual Outcomes in the Protocol W Randomized Trial of Intravitreous Aflibercept for Prevention of Vision-Threatening Complications of Diabetic Retinopathy.

    Maturi, Raj K / Glassman, Adam R / Josic, Kristin / Baker, Carl W / Gerstenblith, Adam T / Jampol, Lee M / Meleth, Annal / Martin, Daniel F / Melia, Michele / Punjabi, Omar S / Rofagha, Soraya / Salehi-Had, Hani / Stockdale, Cynthia R / Sun, Jennifer K

    JAMA

    2024  Volume 329, Issue 5, Page(s) 376–385

    Abstract: Importance: Anti-vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) reduce development of vision-threatening complications from diabetes ... ...

    Abstract Importance: Anti-vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) reduce development of vision-threatening complications from diabetes over at least 2 years, but whether this treatment has a longer-term benefit on visual acuity is unknown.
    Objective: To compare the primary 4-year outcomes of visual acuity and rates of vision-threatening complications in eyes with moderate to severe NPDR treated with intravitreal aflibercept compared with sham. The primary 2-year analysis of this study has been reported.
    Design, setting, and participants: Randomized clinical trial conducted at 64 clinical sites in the US and Canada from January 2016 to March 2018, enrolling 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study [ETDRS] severity level 43-53; range, 0 [worst] to 100 [best]) without CI-DME.
    Interventions: Eyes were randomly assigned to 2.0 mg aflibercept (n = 200) or sham (n = 199). Eight injections were administered at defined intervals through 2 years, continuing quarterly through 4 years unless the eye improved to mild NPDR or better. Aflibercept was given in both groups to treat development of high-risk proliferative diabetic retinopathy (PDR) or CI-DME with vision loss.
    Main outcomes and measures: Development of PDR or CI-DME with vision loss (≥10 letters at 1 visit or ≥5 letters at 2 consecutive visits) and change in visual acuity (best corrected ETDRS letter score) from baseline to 4 years.
    Results: Among participants (mean age 56 years; 42.4% female; 5% Asian, 15% Black, 32% Hispanic, 45% White), the 4-year cumulative probability of developing PDR or CI-DME with vision loss was 33.9% with aflibercept vs 56.9% with sham (adjusted hazard ratio, 0.40 [97.5% CI, 0.28 to 0.57]; P < .001). The mean (SD) change in visual acuity from baseline to 4 years was -2.7 (6.5) letters with aflibercept and -2.4 (5.8) letters with sham (adjusted mean difference, -0.5 letters [97.5% CI, -2.3 to 1.3]; P = .52). Antiplatelet Trialists' Collaboration cardiovascular/cerebrovascular event rates were 9.9% (7 of 71) in bilateral participants, 10.9% (14 of 129) in unilateral aflibercept participants, and 7.8% (10 of 128) in unilateral sham participants.
    Conclusions and relevance: Among patients with NPDR but without CI-DME at 4 years treatment with aflibercept vs sham, initiating aflibercept treatment only if vision-threatening complications developed, resulted in statistically significant anatomic improvement but no improvement in visual acuity. Aflibercept as a preventive strategy, as used in this trial, may not be generally warranted for patients with NPDR without CI-DME.
    Trial registration: ClinicalTrials.gov Identifier: NCT02634333.
    MeSH term(s) Female ; Humans ; Male ; Middle Aged ; Angiogenesis Inhibitors/administration & dosage ; Diabetic Retinopathy/drug therapy ; Diabetic Retinopathy/etiology ; Intravitreal Injections ; Macular Edema/drug therapy ; Macular Edema/etiology ; Receptors, Vascular Endothelial Growth Factor/therapeutic use ; Recombinant Fusion Proteins/therapeutic use ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Treatment Outcome ; Vision Disorders/drug therapy ; Vision Disorders/etiology ; Vision Disorders/prevention & control ; Visual Acuity/drug effects
    Chemical Substances aflibercept (15C2VL427D) ; Angiogenesis Inhibitors ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Recombinant Fusion Proteins ; Vascular Endothelial Growth Factor A
    Language English
    Publishing date 2024-01-22
    Publishing country United States
    Document type Clinical Trial Protocol ; Comparative Study ; Journal Article ; 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.2022.25029
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  3. Article ; Online: Pseudovitelliform maculopathy associated with deferoxamine toxicity: multimodal imaging and electrophysiology of a rare entity.

    Bui, Kelly M / Sadda, SriniVas R / Salehi-Had, Hani

    Digital journal of ophthalmology : DJO

    2017  Volume 23, Issue 1, Page(s) 11–15

    Abstract: ... imaging and electrophysiology. The patient had iron overload related to transfusion-dependent ...

    Abstract Deferoxamine is a commonly used chelating agent for secondary hemochromatosis. We report a rare retinal manifestation of deferoxamine toxicity in a 68-year-old man and provide supporting multimodal imaging and electrophysiology. The patient had iron overload related to transfusion-dependent myelodysplastic syndrome and developed a pseudovitelliform macular lesion related to deferoxamine toxicity. We also describe for the first time the worsening of this maculopathy on deferasirox, an alternative chelating agent. Macular pseudovitelliform lesion is a unique manifestation of deferoxamine toxicity that can be mistaken for pattern dystrophy. It is important to recognize this manifestation, because discontinuation of the offending agent may halt or reverse the toxicity.
    Language English
    Publishing date 2017
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2030129-7
    ISSN 1542-8958 ; 1542-8958
    ISSN (online) 1542-8958
    ISSN 1542-8958
    DOI 10.5693/djo.02.2016.12.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Management of traumatic crystalline lens subluxation and dislocation.

    Salehi-Had, Hani / Turalba, Angela

    International ophthalmology clinics

    2010  Volume 50, Issue 1, Page(s) 167–179

    MeSH term(s) Eye Injuries/complications ; Humans ; Lens Implantation, Intraocular/methods ; Lens Subluxation/etiology ; Lens Subluxation/surgery ; Phacoemulsification/methods ; Treatment Outcome
    Language English
    Publishing date 2010
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 207382-1
    ISSN 1536-9617 ; 0020-8167
    ISSN (online) 1536-9617
    ISSN 0020-8167
    DOI 10.1097/IIO.0b013e3181c567de
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial.

    Brown, David M / Boyer, David S / Do, Diana V / Wykoff, Charles C / Sakamoto, Taiji / Win, Peter / Joshi, Sunir / Salehi-Had, Hani / Seres, András / Berliner, Alyson J / Leal, Sergio / Vitti, Robert / Chu, Karen W / Reed, Kimberly / Rao, Rohini / Cheng, Yenchieh / Sun, Wei / Voronca, Delia / Bhore, Rafia /
    Schmidt-Ott, Ursula / Schmelter, Thomas / Schulze, Andrea / Zhang, Xin / Hirshberg, Boaz / Yancopoulos, George D / Sivaprasad, Sobha

    Lancet (London, England)

    2024  Volume 403, Issue 10432, Page(s) 1153–1163

    Abstract: Background: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results ... ...

    Abstract Background: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO.
    Methods: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries. Eligible patients were adults aged 18 years or older with type 1 or 2 diabetes and centre-involved DMO. Patients were randomly assigned (1:2:1) to intravitreal aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16), following initial monthly dosing. From week 16, dosing intervals for the aflibercept 8 mg groups were shortened if patients met prespecified dose regimen modification criteria denoting disease activity. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48 (non-inferiority margin of 4 letters). Efficacy and safety analyses included all randomly assigned patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT04429503).
    Findings: Between June 29, 2020, and June 28, 2021, 970 patients were screened for eligibility. After exclusions, 660 patients were enrolled and randomly assigned to receive aflibercept 8q12 (n=329), 8q16 (n=164), or 2q8 (n=167); two patients were randomly assigned in error and did not receive treatment. 658 (99·7%) patients were treated and included in the full analysis set and safety analysis set (8q12 n=328, 8q16 n=163, and 2q8 n=167). Mean patient age was 62·3 years (SD 10·4). 401 (61%) patients were male. 471 (72%) patients were White. Aflibercept 8q12 and 8q16 demonstrated non-inferior BCVA gains to aflibercept 2q8 (BCVA mean change from baseline 8·8 letters [SD 9·0] in the 8q12 group, 7·9 letters [8·4] in the 8q16 group, and 9·2 letters [9·0] in the 2q8 group). The difference in least squares means was -0·57 letters (95% CI -2·26 to 1·13, p value for non-inferiority <0·0001) between 8q12 and 2q8 and -1·44 letters (-3·27 to 0·39, p value for non-inferiority 0·0031) between aflibercept 8q16 and 2q8. Proportions of patients with ocular adverse events in the study eye were similar across groups (8q12 n=104 [32%], 8q16 n=48 [29%], and 2q8 n=46 [28%]).
    Interpretation: Aflibercept 8 mg demonstrated efficacy and safety with extended dosing intervals and could decrease treatment burden in patients with DMO.
    Funding: Regeneron Pharmaceuticals and Bayer.
    MeSH term(s) Adult ; Female ; Humans ; Male ; Angiogenesis Inhibitors ; Diabetes Mellitus/drug therapy ; Diabetic Retinopathy ; Macular Edema/etiology ; Macular Edema/chemically induced ; Receptors, Vascular Endothelial Growth Factor/therapeutic use ; Recombinant Fusion Proteins/adverse effects ; Treatment Outcome ; Middle Aged ; Aged
    Chemical Substances aflibercept (15C2VL427D) ; Angiogenesis Inhibitors ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1) ; Recombinant Fusion Proteins
    Language English
    Publishing date 2024-03-07
    Publishing country England
    Document type Clinical Trial, Phase II ; Clinical Trial, Phase III ; Equivalence Trial ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(23)02577-1
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  6. Article ; Online: Long-term Follow-up of a Phase 1/2a Clinical Trial of a Stem Cell-Derived Bioengineered Retinal Pigment Epithelium Implant for Geographic Atrophy.

    Humayun, Mark S / Clegg, Dennis O / Dayan, Margot S / Kashani, Amir H / Rahhal, Firas M / Avery, Robert L / Salehi-Had, Hani / Chen, Sanford / Chan, Clement / Palejwala, Neal / Ingram, April / Mitra, Debbie / Pennington, Britney O / Hinman, Cassidy / Faynus, Mohamed A / Bailey, Jeffrey K / Johnson, Lincoln V / Lebkowski, Jane S

    Ophthalmology

    2023  

    Abstract: Purpose: To report long-term results from a phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in patients with advanced geographic atrophy (GA).: Design: A single-arm, ...

    Abstract Purpose: To report long-term results from a phase 1/2a clinical trial assessment of a scaffold-based human embryonic stem cell-derived retinal pigmented epithelium (RPE) implant in patients with advanced geographic atrophy (GA).
    Design: A single-arm, open-label phase 1/2a clinical trial approved by the United States Food and Drug Administration.
    Participants: Patients were 69-85 years of age at the time of enrollment and were legally blind in the treated eye (best-corrected visual acuity [BCVA], ≤ 20/200) as a result of GA involving the fovea.
    Methods: The clinical trial enrolled 16 patients, 15 of whom underwent implantation successfully. The implant was administered to the worse-seeing eye with the use of a custom subretinal insertion device. The companion nonimplanted eye served as the control. The primary endpoint was at 1 year; thereafter, patients were followed up at least yearly.
    Main outcome measures: Safety was the primary endpoint of the study. The occurrence and frequency of adverse events (AEs) were determined by scheduled eye examinations, including measurement of BCVA and intraocular pressure and multimodal imaging. Serum antibody titers were collected to monitor systemic humoral immune responses to the implanted cells.
    Results: At a median follow-up of 3 years, fundus photography revealed no migration of the implant. No unanticipated, severe, implant-related AEs occurred, and the most common anticipated severe AE (severe retinal hemorrhage) was eliminated in the second cohort (9 patients) through improved intraoperative hemostasis. Nonsevere, transient retinal hemorrhages were noted either during or after surgery in all patients as anticipated for a subretinal surgical procedure. Throughout the median 3-year follow-up, results show that implanted eyes were more likely to improve by > 5 letters of BCVA and were less likely to worsen by > 5 letters compared with nonimplanted eyes.
    Conclusions: This report details the long-term follow-up of patients with GA to receive a scaffold-based stem cell-derived bioengineered RPE implant. Results show that the implant, at a median 3-year follow-up, is safe and well tolerated in patients with advanced dry age-related macular degeneration. The safety profile, along with the early indication of efficacy, warrants further clinical evaluation of this novel approach for the treatment of GA.
    Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
    Language English
    Publishing date 2023-12-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 392083-5
    ISSN 1549-4713 ; 0161-6420
    ISSN (online) 1549-4713
    ISSN 0161-6420
    DOI 10.1016/j.ophtha.2023.12.028
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  7. 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: ... years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was ...

    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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  8. 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: ... 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 ... 800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone ...

    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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  9. Article ; Online: Detection of airbag impact-induced cone photoreceptor damage by adaptive optics scanning laser ophthalmoscopy: a case report.

    Kaizu, Yoshihiro / Nakao, Shintaro / Yamaguchi, Muneo / Murakami, Yusuke / Salehi-Had, Hani / Ishibashi, Tatsuro

    BMC ophthalmology

    2016  Volume 16, Page(s) 99

    Abstract: Background: The purpose of this study was to report a case of traumatic maculopathy with para-central visual field defects following an impact by airbag deployment using adaptive optics scanning laser ophthalmoscopy (AO-SLO).: Case presentation: A 51- ...

    Abstract Background: The purpose of this study was to report a case of traumatic maculopathy with para-central visual field defects following an impact by airbag deployment using adaptive optics scanning laser ophthalmoscopy (AO-SLO).
    Case presentation: A 51-year-old man was involved in a motor vehicular accident and his left eye was struck by the deployed airbag, resulting in a para-central scotoma. The patient underwent a full ophthalmologic examination, spectral-domain optical coherence tomography (SD-OCT), and imaging with prototype AO-SLO systems (Canon Inc.) at 14 and 22 months after the injury. Images focused on the photoreceptor layer were recorded in the foveal area, and a montage of AO-SLO images was created. On AO-SLO, focal dark areas could be observed in the left eye at 14 months after the injury. The analysis showed that the cone mosaic (cone density, 16503/mm(2); ratio of hexagonal Voronoi domain, 36.3 %; average nearest-neighbor distance (NND)/expected NND, 0.606) was disordered compared with the normal area of the same eye (cone density, 24821/mm(2); ratio of hexagonal Voronoi domain, 44.1 %; average NND/expected NND, 0.739). The cone defect area corresponded to the area of the scotoma. A second AO-SLO was performed on the patient at 22 months after the injury and although there were still areas with reduced cone reflectivity, partial improvement of cone mosaic was detected by AO-SLO at this time point.
    Conclusion: Partial recovery of damaged cone photoreceptors following closed globe blunt ocular trauma can be documented using AO-SLO longitudinal tracking.
    MeSH term(s) Air Bags ; Eye Injuries/complications ; Fluorescein Angiography ; Humans ; Male ; Middle Aged ; Ophthalmoscopy/methods ; Optics and Photonics ; Retinal Cone Photoreceptor Cells/pathology ; Retinal Diseases/diagnosis ; Scotoma/diagnosis
    Language English
    Publishing date 2016-07-08
    Publishing country England
    Document type Case Reports ; Journal Article
    ZDB-ID 2050436-6
    ISSN 1471-2415 ; 1471-2415
    ISSN (online) 1471-2415
    ISSN 1471-2415
    DOI 10.1186/s12886-016-0275-4
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  10. Article ; Online: Survival of an HLA-mismatched, bioengineered RPE implant in dry age-related macular degeneration.

    Kashani, Amir H / Lebkowski, Jane S / Hinton, David R / Zhu, Danhong / Faynus, Mohamed A / Chen, Sanford / Rahhal, Firas M / Avery, Robert L / Salehi-Had, Hani / Chan, Clement / Palejwala, Neal / Ingram, April / Dang, Wei / Lin, Chih-Min / Mitra, Debbie / Martinez-Camarillo, Juan Carlos / Bailey, Jeff / Arnold, Cassidy / Pennington, Britney O /
    Rao, Narsing / Johnson, Lincoln V / Clegg, Dennis O / Humayun, Mark S

    Stem cell reports

    2022  Volume 17, Issue 3, Page(s) 448–458

    Abstract: Cell-based therapies face challenges, including poor cell survival, immune rejection, and integration into pathologic tissue. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy of a subretinal implant ... ...

    Abstract Cell-based therapies face challenges, including poor cell survival, immune rejection, and integration into pathologic tissue. We conducted an open-label phase 1/2a clinical trial to assess the safety and preliminary efficacy of a subretinal implant consisting of a polarized monolayer of allogeneic human embryonic stem cell-derived retinal pigmented epithelium (RPE) cells in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration. Postmortem histology from one subject with very advanced disease shows the presence of donor RPE cells 2 years after implantation by immunoreactivity for RPE65 and donor-specific human leukocyte antigen (HLA) class I molecules. Markers of RPE cell polarity and phagocytosis suggest donor RPE function. Further histologic examination demonstrated CD34
    MeSH term(s) Geographic Atrophy/therapy ; Human Embryonic Stem Cells/pathology ; Humans ; Macular Degeneration/pathology ; Macular Degeneration/therapy ; Prostheses and Implants/adverse effects ; Retinal Pigment Epithelium/pathology
    Language English
    Publishing date 2022-02-03
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2720528-9
    ISSN 2213-6711 ; 2213-6711
    ISSN (online) 2213-6711
    ISSN 2213-6711
    DOI 10.1016/j.stemcr.2022.01.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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