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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04140448
Acronym
UWFA-RVO-ME
Enrollment
60
Registered
2019-10-25
Start date
2023-10-09
Completion date
2025-12-15
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Retinal Vein Occlusion

Keywords

Ultra-wide field fundus fluorescein angiography, ischemic index, leakage index

Brief 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.

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.

Interventions

Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML

DEVICEUltra-wide Fluorescein Angiography

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

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in vascular leakage index in different retinal areaBaseline and 1,2,3,4,6,9 and 12 monthsChange in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Change in non-perfused areas in different retinal areaBaseline and 1,2,3,4,6,9 and 12 monthsChange in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months

Secondary

MeasureTime frameDescription
Change in best corrected visual acuityBaseline and 1,2,3,4,6,9 and 12 monthsChange in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months
Change in central macular thicknessBaseline and 1,2,3,4,6,9 and 12 monthsChange in central macular thickness from baseline to1,2,3,4,6,9 and12 months

Countries

China

Contacts

Primary ContactCZ Chen, PHD
whuchenchzh@163.com+86 13072765173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026