Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion

Recruiting

• Conditions: Retinal Vein Occlusion

• Registration Number: NCT04075695
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

The changes of ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion by ultra-wide field fluorescence angiography (UWFA)

Detailed Description

In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Study Start: 2019-09-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-12-12
• Study Completion: 2025-08-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female aged 18 years or more
2. Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
3. Duration of RVO not more than 4 months
4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive
5. Patient who agrees to participate to the study and who has given his/her written, informed consent

Exclusion Criteria

1. Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
2. Active or suspected ocular or periocular infection
3. Active severe intraocular inflammation
4. RVO complicated with neovascularization
5. Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
6. Patient already included in the study for the treatment of the fellow eye
7. Pregnant or breastfeeding woman
8. Lack of effective contraception for women of childbearing age
9. Patient taking part in an interventional study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in non-perfused areas in different retinal area	Baseline and1，2，3，6，9and 12 months	Change in non-perfused areas in different retinal area from Baseline to 1，2，3，6，9and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in central macular thickness	Baseline and1，2， 3, 6, 9 and 12 months	Change in central macular thickness from Baseline to 1，2，3，6，9and 12 months
Change in best corrected visual acuity	Baseline and1，2， 3, 6, 9 and 12 months	Change in best corrected visual acuity from Baseline to 1，2，3，6，9and 12 months

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China