Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion (UWFA-RVO-ME)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: CZ Chen, PHD; Phone Number: +86 13072765173; Email: whuchenchzh@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: CZ Chen, PHD; Phone Number: +86 13072765173; Email: whuchenchzh@163.com
      • Contact: XL Wang; Phone Number: +86 13117192316; Email: wangxl0807@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UWFA-RVO-ME; 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]; Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML; Other Names: Lucentis; Anti-VEGF; Device: Ultra-wide Fluorescein Angiography; Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Principal Investigator: CZ Chen, PHD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 9, 2023
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ultra-wide field fundus fluorescein angiography; ischemic index; leakage index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: UWFA-RVO-ME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No