Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion

Recruiting

• Conditions: Retinal Vein Occlusion; Macular Edema
• Interventions: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]; Device: Ultra-wide Fluorescein Angiography

• Registration Number: NCT04140448
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.

Detailed Description

Ultra-wide field fluorescence angiography can clearly observe the peripheral retina. This study mainly observes the ischemic index and vascular leakage index changes on UWFA after anti-VEGF treatment and evaluates these changes associated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Status Verified: 2023-10
• Study Start: 2023-10-09
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-10-30
• Study Completion: 2025-12-15

Recruitment & Eligibility

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

Inclusion Criteria

1. Male or female aged 18 years or older
2. Macular edema secondary to CRVO,BRVO or HRVO
3. Duration of RVO not more than 4 months
4. Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive
5. Patient who agrees to participate in 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

Arm && Interventions

Group	Intervention	Description
UWFA-RVO-ME	Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]	Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab
UWFA-RVO-ME	Ultra-wide Fluorescein Angiography	Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab

Primary Outcome Measures

Name	Time	Method
Change in non-perfused areas in different retinal area	Baseline and 1,2,3,4,6,9 and 12 months	Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Change in vascular leakage index in different retinal area	Baseline and 1,2,3,4,6,9 and 12 months	Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in best corrected visual acuity	Baseline and 1,2,3,4,6,9 and 12 months	Change in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months
Change in central macular thickness	Baseline and 1,2,3,4,6,9 and 12 months	Change in central macular thickness from baseline to1,2,3,4,6,9 and12 months

Trial Locations

Locations (1)

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