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  1. Article ; Online: Clinical Trials in Branch Retinal Vein Occlusion.

    Panakanti, Tandava Krishnan / Chhablani, Jay

    Middle East African journal of ophthalmology

    2016  Volume 23, Issue 1, Page(s) 38–43

    Abstract: Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder ... a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have ... from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special ...

    Abstract Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF) have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept) compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular) of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.
    MeSH term(s) Angiogenesis Inhibitors/therapeutic use ; Bevacizumab/therapeutic use ; Clinical Trials as Topic ; Humans ; Intravitreal Injections ; Macular Edema/drug therapy ; Macular Edema/physiopathology ; Ranibizumab/therapeutic use ; Receptors, Vascular Endothelial Growth Factor/therapeutic use ; Recombinant Fusion Proteins/therapeutic use ; Retinal Vein Occlusion/drug therapy ; Retinal Vein Occlusion/physiopathology ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/drug effects ; 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 2016-01
    Publishing country India
    Document type Journal Article ; Review
    ZDB-ID 2545467-5
    ISSN 0975-1599 ; 0974-9233
    ISSN (online) 0975-1599
    ISSN 0974-9233
    DOI 10.4103/0974-9233.172294
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Clinical trials in branch retinal vein occlusion

    Tandava Krishnan Panakanti / Jay Chhablani

    Middle East African Journal of Ophthalmology, Vol 23, Iss 1, Pp 38-

    2016  Volume 43

    Abstract: Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder ... a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have ... from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special ...

    Abstract Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF) have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept) compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular) of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.
    Keywords Anti-Vascular Endothelial Growth Factors ; Branch Retinal Vein Occlusion ; Clinical Trials ; Macular Edema ; Ophthalmology ; RE1-994 ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2016-01-01T00:00:00Z
    Publisher Medknow Publications
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article: Role of aflibercept for macular edema following branch retinal vein occlusion: comparison of clinical trials.

    Oellers, Patrick / Grewal, Dilraj S / Fekrat, Sharon

    Clinical ophthalmology (Auckland, N.Z.)

    2016  Volume 10, Page(s) 411–418

    Abstract: For years, the standard of care for branch-retinal-vein-occlusion-associated macular edema was ... pharmacologic options have revolutionized the management of branch-retinal-vein-occlusion-associated ... summarizes the available clinical studies with special emphasis on the comparison of intravitreal aflibercept ...

    Abstract For years, the standard of care for branch-retinal-vein-occlusion-associated macular edema was initial observation followed by grid-pattern laser photocoagulation for persistent edema. Newer pharmacologic options have revolutionized the management of branch-retinal-vein-occlusion-associated macular edema, and the visual outcomes of these eyes are better than ever. However, a variety of available treatment options including intravitreal corticosteroids and intravitreal anti-vascular endothelial growth factor agents have established novel challenges with regard to appropriate drug selection. This review summarizes the available clinical studies with special emphasis on the comparison of intravitreal aflibercept with ranibizumab, bevacizumab, and steroid agents.
    Language English
    Publishing date 2016-03-08
    Publishing country New Zealand
    Document type Journal Article ; Review
    ISSN 1177-5467
    ISSN 1177-5467
    DOI 10.2147/OPTH.S98853
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Intravitreal triamcinolone for acute branch retinal vein occlusion: a randomized clinical trial.

    Ramezani, Alireza / Entezari, Morteza / Moradian, Siamak / Kadkhodaei, Shohreh / Tabatabaei, Homa / Dehsarvi, Babak / Fatehi, Mohammad / Yaseri, Mehdi

    Journal of ophthalmic & vision research

    2012  Volume 6, Issue 2, Page(s) 101–108

    Abstract: ... for recent branch retinal vein occlusion (BRVO).: Methods: In a randomized controlled clinical trial, 30 ... to the natural history of the condition. The 3-month deferred treatment protocol advocated by the Branch Vein Occlusion ...

    Abstract Purpose: To evaluate the therapeutic effect of intravitreal triamcinolone (IVT) injection for recent branch retinal vein occlusion (BRVO).
    Methods: In a randomized controlled clinical trial, 30 phakic eyes with recent (less than 10 weeks' duration) BRVO were assigned to two groups. The treatment group (16 eyes) received 4 mg IVT and the control group (14 eyes) received subconjunctival sham injections. Changes in visual acuity (VA) were the main outcome measure.
    Results: VA and central macular thickness (CMT) changes were not significantly different between the study groups at any time point. Within group analysis showed significant VA improvement from baseline in the IVT group up to three months (P < 0.05); the amount of this change was -0.53 ± 0.46, -0.37 ± 0.50, -0.46 ± 0.50, and -0.29 ± 0.45 logMAR at 1, 2, 3, and 4 months, respectively. Corresponding VA improvements in the control group were -0.20 ± 0.37, -0.11 ± 0.46, -0.25 ± 0.58, and -0.05 ± 0.50 logMAR (all P values > 0.05). Significant reduction in CMT was noticed only in the treatment group (-172 ± 202 μm, P = 0.029) and at 4 months. Ocular hypertension occurred in 4 (25%) and 2 (14.3%) eyes in the IVT and control groups, respectively.
    Conclusion: A single IVT injection had a non-significant beneficial effect on VA and CMT in acute BRVO as compared to the natural history of the condition. The 3-month deferred treatment protocol advocated by the Branch Vein Occlusion Study Group may be a safer option than IVT injection considering its potential side effects.
    Language English
    Publishing date 2012-02-19
    Publishing country India
    Document type Journal Article
    ZDB-ID 2578268-X
    ISSN 2008-322X ; 2008-322X
    ISSN (online) 2008-322X
    ISSN 2008-322X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES): six-month results of a prospective randomized clinical trial.

    Pielen, Amelie / Mirshahi, Alireza / Feltgen, Nicolas / Lorenz, Katrin / Korb, Christina / Junker, Bernd / Schaefer, Caroline / Zwiener, Isabella / Hattenbach, Lars-Olof

    Acta ophthalmologica

    2015  Volume 93, Issue 1, Page(s) e29–37

    Abstract: ... to branch retinal vein occlusion.: Methods: Prospective, randomized, multicentre clinical trial. Thirty ... in central retinal thickness (CRT) was 90.6 μm (laser) (-18.65; 199.8), 379.5 μm (IVR) (204.2; -554.8), and ...

    Abstract Purpose: To compare standard-of-care grid laser photocoagulation versus intravitreal ranibizumab (IVR) versus a combination of both in the treatment of chronic (>3 months) macular oedema secondary to branch retinal vein occlusion.
    Methods: Prospective, randomized, multicentre clinical trial. Thirty patients with a best-corrected visual acuity (BCVA) between 20/320 and 20/40 were randomized 1:1:1 to receive grid laser or three monthly injections of 0.5 mg IVR or both followed by 3 months of observation.
    Results: Mean change from baseline BCVA at month 6 was +2 letters [laser; 0.04 logMAR, 95% confidence interval (-0.17; 0.25)], +17 letters [IVR; 0.34 (0.19; 0.5)] and +6 letters [combination; 0.12 (0.01; 0.24)] (IVR versus laser p = 0.02 and IVR versus combination p = 0.02). At month 3, mean improvement in central retinal thickness (CRT) was 90.6 μm (laser) (-18.65; 199.8), 379.5 μm (IVR) (204.2; -554.8), and 248 μm (167.2; -328.8) (combination) (IVR versus laser p = 0.005, laser versus combination p = 0.02). During the observation period, CRT improved in laser [37.6 μm (-66.82; 142.0)], but deteriorated in IVR [-142.4 μm (-247.6; -37.16)] and combination [-171.7 μm (-250.4; -92.96)] (laser versus IVR p = 0.01, laser versus combination p = 0.002) indicating recurrent oedema. Less laser retreatments (at 8 weeks) were required in combination group (2/10) than grid group (7/10).
    Conclusion: Six-month results suggest that ranibizumab may be superior to grid laser in improving visual acuity. Grid combined with IVR neither enhanced functional and morphological improvement of IVR nor did it prevent or prolong recurrence of oedema. In IVR groups, CRT increased slowly after stopping injections, whereas improvement in visual acuity was sustained, indicating that morphological changes occur prior to functional impairment.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Combined Modality Therapy ; Female ; Humans ; Intravitreal Injections ; Laser Coagulation/methods ; Lasers, Semiconductor/therapeutic use ; Macular Edema/drug therapy ; Macular Edema/surgery ; Macular Edema/therapy ; Male ; Middle Aged ; Prospective Studies ; Ranibizumab ; Recurrence ; Retinal Vein Occlusion/drug therapy ; Retinal Vein Occlusion/surgery ; Retinal Vein Occlusion/therapy ; Vascular Endothelial Growth Factor A/antagonists & inhibitors ; Visual Acuity/physiology
    Chemical Substances Angiogenesis Inhibitors ; Antibodies, Monoclonal, Humanized ; VEGFA protein, human ; Vascular Endothelial Growth Factor A ; Ranibizumab (ZL1R02VT79)
    Language English
    Publishing date 2015-02
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2408333-1
    ISSN 1755-3768 ; 1755-375X
    ISSN (online) 1755-3768
    ISSN 1755-375X
    DOI 10.1111/aos.12488
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Dalteparin versus aspirin in recent-onset branch retinal vein occlusion: a randomized clinical trial.

    Farahvash, Mohammad-Sadegh / Moradimogadam, Marzieh / Farahvash, Mohammad-Mehdi / Mohammadzadeh, Shiva / Mirshahi, Ahmad

    Archives of Iranian medicine

    2008  Volume 11, Issue 4, Page(s) 418–422

    Abstract: ... A randomized clinical trial was conducted on patients with branch retinal vein occlusion of less than 30 days' ... the effect of dalteparin and aspirin in patients with recent-onset branch retinal vein occlusion.: Methods ... 0.08) and (P=0.49), respectively].: Conclusion: In recent-onset branch retinal vein occlusion, no ...

    Abstract Background: Retinal vein occlusion is the second most common vascular disease of retina after diabetic retinopathy, affecting 1.6% of the population above the age of 40. The aim of this study was to compare the effect of dalteparin and aspirin in patients with recent-onset branch retinal vein occlusion.
    Methods: A randomized clinical trial was conducted on patients with branch retinal vein occlusion of less than 30 days' duration. Ophthalmic, systemic, and hematologic evaluations were made. Visual acuity was measured with Early Treatment Diabetic Retinopathy Study chart. Patients in the dalteparin group received subcutaneous dalteparin 100 IU/kg twice daily for 10 days, then 100 IU/kg once daily for another 10 days while the patients in the aspirin group were given aspirin 100 mg daily throughout the study.
    Results: Seventy-eight patients were enrolled, 37 in the dalteparin and 41 in the aspirin group. The patients were followed for six months. The visual outcomes of the two groups were compared. Although dalteparin improved mean visual acuity slightly more than aspirin, no statistically significant differences were found between the groups at one (P=0.37), two (P=0.16), three (P=0.11), or six (P=0.13) months. Resolution of macular edema and development of new vessels made no statistically significant difference between the groups [(P=0.08) and (P=0.49), respectively].
    Conclusion: In recent-onset branch retinal vein occlusion, no significant difference was found in the final visual acuity between the patients treated by dalteparin or aspirin. A further study with larger sample size is recommended.
    MeSH term(s) Aspirin/therapeutic use ; Dalteparin/therapeutic use ; Female ; Fibrinolytic Agents/therapeutic use ; Humans ; Male ; Middle Aged ; Retinal Vein Occlusion/drug therapy ; Time Factors
    Chemical Substances Fibrinolytic Agents ; Aspirin (R16CO5Y76E) ; Dalteparin (S79O08V79F)
    Language English
    Publishing date 2008-07
    Publishing country Iran
    Document type Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2204979-4
    ISSN 1029-2977
    ISSN 1029-2977
    DOI 08114/AIM.0013
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: Argon laser scatter photocoagulation in treatment of branch retinal vein occlusion. A prospective clinical trial.

    Hayreh, S S / Rubenstein, L / Podhajsky, P

    Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde

    1993  Volume 206, Issue 1, Page(s) 1–14

    Abstract: ... photocoagulation to the involved sector in major branch retinal vein occlusion and ischemic hemicentral retinal vein ... occlusion (a) prevents development of retinal and/or optic disk neovascularization and vitreous hemorrhage ... and (b) affects visual acuity, visual fields and macular retinal lesions. The study was done in 271 ...

    Abstract The objective of this prospective study was to ascertain whether scatter argon laser photocoagulation to the involved sector in major branch retinal vein occlusion and ischemic hemicentral retinal vein occlusion (a) prevents development of retinal and/or optic disk neovascularization and vitreous hemorrhage, and (b) affects visual acuity, visual fields and macular retinal lesions. The study was done in 271 eyes allocated to either treated (n = 61 eyes) or untreated (n = 210) groups. In this study, on an average follow-up of 3.6 years, the laser treatment (1) significantly reduced the risk of development of retinal neovascularization and vitreous hemorrhage, (2) did not affect the visual acuity and macular retinal lesions, and (3) produced a significant worsening in the peripheral visual fields compared to the untreated eyes. In view of our findings, we recommend that argon laser photocoagulation treatment should be given only when neovascularization is seen and not otherwise, because in the latter case, its detrimental effects may outweigh its beneficial ones.
    MeSH term(s) Aged ; Argon ; Female ; Follow-Up Studies ; Humans ; Incidence ; Laser Coagulation/methods ; Male ; Middle Aged ; Neovascularization, Pathologic/etiology ; Neovascularization, Pathologic/prevention & control ; Optic Disk/blood supply ; Prospective Studies ; Recurrence ; Retinal Diseases/etiology ; Retinal Diseases/prevention & control ; Retinal Neovascularization/etiology ; Retinal Neovascularization/prevention & control ; Retinal Vein Occlusion/complications ; Retinal Vein Occlusion/surgery ; Visual Acuity ; Visual Fields ; Vitreous Hemorrhage/etiology ; Vitreous Hemorrhage/prevention & control
    Chemical Substances Argon (67XQY1V3KH)
    Language English
    Publishing date 1993
    Publishing country Switzerland
    Document type Clinical Trial ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 209735-7
    ISSN 1423-0267 ; 0030-3755
    ISSN (online) 1423-0267
    ISSN 0030-3755
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Experimental retinal branch vein occlusion in rhesus monkeys. I. Clinical appearances.

    Hamilton, A M / Kohner, E M / Rosen, D / Bird, A C / Dollery, C T

    The British journal of ophthalmology

    1979  Volume 63, Issue 6, Page(s) 377–387

    Abstract: Branch and hemisphere vein occlusion were produced in rhesus monkeys by argon laser ... those seen in human retinal vein occlusion, though persistent retinal oedema and preretinal ... delayed filling of the artery, delayed drainage by the occluded vein, and capillary leakage. (2) Two ...

    Abstract Branch and hemisphere vein occlusion were produced in rhesus monkeys by argon laser photocoagulation. The following observations were made: (1) Immediately after occlusion there was venous dilatation, delayed filling of the artery, delayed drainage by the occluded vein, and capillary leakage. (2) Two patterns of evolution were identified within the first week. In some animals the fundus changes resolved and the retina returned to normal, while in others there was progressive retinal capillary closure. (3) Those animals destined to have capillary closure had diffuse or cluster retinal haemorrhages at 24 hours. (4) Capillary closure took place over 1 week and was usually complete over large areas of retina. (5) Retinal atrophy and major vessel changes occurred over several weeks. (6) Retinal revascularisation occurred in those areas of closure, though this was often limited. It was concluded that the early changes mimicked those seen in human retinal vein occlusion, though persistent retinal oedema and preretinal neovascularisation were not identified.
    MeSH term(s) Animals ; Capillaries/pathology ; Constriction, Pathologic ; Edema/etiology ; Fluorescein Angiography ; Haplorhini ; Macaca mulatta ; Retinal Diseases/etiology ; Retinal Hemorrhage/etiology ; Retinal Vein/pathology ; Time Factors ; Vascular Diseases/pathology
    Language English
    Publishing date 1979-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 80078-8
    ISSN 1468-2079 ; 0007-1161
    ISSN (online) 1468-2079
    ISSN 0007-1161
    DOI 10.1136/bjo.63.6.377
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale.

    Hattenbach, Lars-Olof / Abreu, Francis / Arrisi, Pablo / Basu, Karen / Danzig, Carl J / Guymer, Robyn / Haskova, Zdenka / Heier, Jeffrey S / Kotecha, Aachal / Liu, Ying / Loewenstein, Anat / Seres, András / Willis, Jeffrey R / Wykoff, Charles C / Paris, Liliana P

    Ophthalmology science

    2023  Volume 3, Issue 3, Page(s) 100302

    Abstract: ... safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).: Design ... age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy ... Participants: Anti-VEGF treatment-naive patients with branch, central, or hemiretinal RVO.: Methods ...

    Abstract Purpose: Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).
    Design: Two identically designed global, randomized, double-masked, active comparator-controlled studies.
    Participants: Anti-VEGF treatment-naive patients with branch, central, or hemiretinal RVO.
    Methods: Patients were randomized to 6 monthly injections of faricimab 6.0 mg or aflibercept 2.0 mg. From weeks 24 to 72, all patients received faricimab 6.0 mg administered in up to 16-week intervals using an automated treatment algorithm to generate a treat-and-extend-based personalized treatment interval dosing regimen. Personalized treatment interval adjustments were based on changes in central subfield thickness (CST) and best-corrected visual acuity (BCVA).
    Main outcome measures: Primary end point was noninferiority of faricimab versus aflibercept in mean change from baseline in BCVA (week 24; noninferiority margin: 4 letters). Secondary end points (weeks 0-24) were mean change from baseline in BCVA, CST, and National Eye Institute Visual Function Questionnaire 25 composite score; proportion of patients gaining or avoiding loss of ≥ 15/≥ 10/≥ 5/> 0 letters. Secondary end points (weeks 24-72) were treatment durability (week 68); continuation of weeks 0 to 24 end points. Ocular/nonocular adverse events will be assessed.
    Results: In total, 1282 patients across 22 countries were enrolled (BALATON, 553 patients, 149 centers; COMINO, 729 patients, 193 centers).
    Conclusions: Using a novel automated interval algorithm, BALATON/COMINO will evaluate the efficacy and safety of faricimab for ME secondary to RVO and provide key insights into how to personalize treatment.
    Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
    Language English
    Publishing date 2023-03-27
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2666-9145
    ISSN (online) 2666-9145
    DOI 10.1016/j.xops.2023.100302
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial.

    Yao, Bangtao / Wang, Bei / Yang, Jun / Geng, Yan / Yu, Hao / Liu, Yuhui / Liu, Gang / Wang, Xiuying

    Trials

    2024  Volume 25, Issue 1, Page(s) 244

    Abstract: ... have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO ... CP).: Methods and analysis: A prospective randomized controlled clinical trial will be conducted ... submitted to a peer-reviewed journal.: Trial registration: Chinese Clinical Trial Registry ...

    Abstract Introduction: Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs have been widely used in patients with macular edema (ME) secondary to retinal vein occlusion (RVO); however, recurrence is a major concern. This study aims to observe the clinical effects of atorvastatin and intravitreal therapy in the treatment of patients with branch or central RVO-ME and coexistent carotid plaques (CP).
    Methods and analysis: A prospective randomized controlled clinical trial will be conducted. Sixty-four patients diagnosed with branch or central RVO-ME and coexistent CP will be enrolled and randomly allocated in a 1:1 ratio to the control and experimental groups. The control group will be treated with intravitreal conbercept monthly for 3 months, followed by monthly evaluation and injection of pro re nata (PRN) for 12 months, while the experimental group will be treated with oral atorvastatin 20 mg daily combined with the control group treatment. If a drop of best-corrected visual acuity (BCVA) is more than five Early Treatment Diabetic Retinopathy Study (ETDRS) letters (one line) or an increment in central subfield thickness (CSFT) of 100 μm (or a 10% increment from the previous visit), intravitreal re-treatment will be performed. Outcome measurements include CSFT, BCVA, number of injections, and incidence of adverse events during the 12-month follow-up period. Differences between groups will be evaluated using Student's t-test, and comparisons between groups will be evaluated using repeated-measures analysis of variance.
    Ethics and dissemination: The study has been approved by the Institutional Review Board of Nanjing Lishui People's Hospital, Nanjing, China (approval number 2023KY0418-12, dated 18 April 2023), and has been registered on chictr.org.cn. Written informed consent will be collected from each patient and the results of this trial will be submitted to a peer-reviewed journal.
    Trial registration: Chinese Clinical Trial Registry ChiCTR2300071359. Registered on 12 May 2023.
    MeSH term(s) Humans ; Macular Edema/diagnosis ; Macular Edema/drug therapy ; Macular Edema/etiology ; Retinal Vein Occlusion/complications ; Retinal Vein Occlusion/diagnosis ; Retinal Vein Occlusion/drug therapy ; Angiogenesis Inhibitors ; Atorvastatin/adverse effects ; Prospective Studies ; Treatment Outcome ; Tomography, Optical Coherence ; Randomized Controlled Trials as Topic ; Recombinant Fusion Proteins
    Chemical Substances Angiogenesis Inhibitors ; Atorvastatin (A0JWA85V8F) ; KH902 fusion protein (1P05PW62F3) ; Recombinant Fusion Proteins
    Language English
    Publishing date 2024-04-08
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-024-08082-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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