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

Retinal Vein Occlusion Clinical Trial

— UWFARVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075695
• Other study ID #: UWFARVO
• Status: Recruiting
• Start date: September 18, 2019
• Est. completion date: August 12, 2025

Study information

• Verified date: October 2023
• Source: Renmin Hospital of Wuhan University
• Contact: CZ Chen, PHD
• Phone: +86 13072765173
• Email: whuchenchzh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 12, 2025
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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