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

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)

Study Overview

• Status: Recruiting
• Conditions: Retinal Vein Occlusion

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: CZ Chen, PHD; Phone Number: +86 13072765173; Email: whuchenchzh@163.com
• Study Contact Backup: Name: XL Wang; Phone Number: +86 13117192316; Email: wangxl0807@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • 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 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in non-perfused areas in different retinal area	Change in non-perfused areas in different retinal area from Baseline to 1，2，3，6，9and 12 months	Baseline and1，2，3，6，9and 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 1，2，3，6，9and 12 months	Baseline and1，2， 3, 6, 9 and 12 months
Change in central macular thickness	Change in central macular thickness from Baseline to 1，2，3，6，9and 12 months	Baseline and1，2， 3, 6, 9 and 12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Estimated): December 12, 2024
• Study Completion (Estimated): August 12, 2025

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 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; vascular leakage index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion
• Other Study ID Numbers: UWFARVO

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