Study of Treat and Extend Regimen using Aflbercept for macular edema (CRVO-ME) associated with central retinal vein occlusio

Not Applicable

Recruiting

• Conditions: Central retinal vein occlusion with macular edema

• Registration Number: JPRN-UMIN000031718
• Lead Sponsor: Shinshu University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1) Binocular CRVO 2) Glaucoma with poor control (intraocular pressure > 24 mmHg) 3) High blood pressure with poor control 4) Decreased visual acuity due to non-CRVO-ME in the target eye (age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular forebrain, atrophy of the macula) 5) iris neovascularization, vitreous hemorrhage, traction retinal detachment in the target eye 6) Topical steroid administration within the past 180 days for the target eye 7) Anti-VEGF drug within the past 90 days for the target eye Intravitreal injection 8) Cataract surgery history within the past 90 days for the target eye 9) posterior capsule opening operation within the past 30 days for the target eye 10) All intraocular surgical history within the past 90 days for the target eye 11) Pan-retinal photocoagulation in the target eye 12) Intermediate translucers difficult to obtain fundus photographs and OCT images in the target eyes 13) Administration of systemic angiogenesis inhibitor within 180 days from the scheduled initial dose of Afli Berceptet 14) Cerebrovascular disorder and / or myocardial infarction within 180 days from the scheduled initial dose of Afli Berceptet 15) Renal failure that may require dialysis or dialysis 16) Systemic diseases requiring the administration of drugs that may affect the results of this study 17) Patients with a history of hypersensitivity to the ingredients of this drug 18) Patients infected with eyes or around the eyes, or patients suspected to be infected 19) Patients with severe inflammation in the eye 20) Pregnant women or women who may be pregnant 21) Women who are breastfeeding 22) Patients who wish to have childbirth or do not want contraception during the research period 23) Fluorescein allergy 24) Participation in another trial within 30 days from the scheduled date of Afriveltept's first dose

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average change in best corrected visual acuity (BCVA) at week 24 from baseline.

Secondary Outcome Measures

Name	Time	Method
1. Average change in BCVA from baseline to week 52. 2. Average change of Center Retinal Thickness by Optical Coherence Tomography (OCT) from baseline to week 24 and 52. 3. Comparison and change of foveal avascular zone (FAZ), Vascular Density in each layers by OCT Angiography (OCTA) at week 24 and 52. 4. Evaluation of avascular field (NPA) by fluorescence angiography (FA) examination at Baseline, week 24 and week 52. 5. Change in retina sensitivity by microperimetry (MP-3) from baseline to week 4, week 24, week 52. 6. The average number of Aflibercept administration (times per year) until week 52, and the injection interval until week 52 and at week 52. 7. Change in Quality Of Vision by NEI-VFQ-25 from Baseline to Week 24 and Week 52.