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

Macular Edema Clinical Trial

— UWFA-RVO-ME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140448
• Other study ID #: UWFA-RVO-ME
• Status: Recruiting
• Start date: October 9, 2023
• Est. completion date: December 15, 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML

Device:
• Ultra-wide Fluorescein Angiography
Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina

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 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
Primary	Change in non-perfused areas in different retinal area	Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months	Baseline and 1,2,3,4,6,9 and 12 months
Secondary	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
Secondary	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