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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
* Device: Ultra-wide Fluorescein Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years or older Macular edema secondary to CRVO,BRVO or HRVO Duration of RVO not more than 4 months 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 Patient who agrees to participate in the study and who has given his/her written, informed consent Exclusion Criteria: 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 Active or suspected ocular or periocular infection Active severe intraocular inflammation RVO complicated with neovascularization Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye Patient already included in the study for the treatment of the fellow eye Pregnant or breastfeeding woman Lack of effective contraception for women of childbearing age Patient taking part in an interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UWFA-RVO-ME<br>Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]<br>* Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML<br>* Other names: Anti-VEGF;Device: Ultra-wide Fluorescein Angiography<br>* Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular leakage index in different retinal area | Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months | Baseline and 1,2,3,4,6,9 and 12 months | 
| Change in non-perfused areas in different retinal area | Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months | Baseline and 1,2,3,4,6,9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best corrected visual acuity | Change in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months | Baseline and 1,2,3,4,6,9 and 12 months | 
| Change in central macular thickness | Change in central macular thickness from baseline to1,2,3,4,6,9 and12 months | Baseline and 1,2,3,4,6,9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultra-wide field fundus fluorescein angiography, ischemic index, leakage index