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

W

Wuhan University

Status

Enrolling

Conditions

Macular Edema
Retinal Vein Occlusion

Treatments

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
Device: Ultra-wide Fluorescein Angiography

Study type

Observational

Funder types

Other

Identifiers

NCT04140448
UWFA-RVO-ME

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

UWFA-RVO-ME
Description:
Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab
Treatment:
Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]
Device: Ultra-wide Fluorescein Angiography

Trial contacts and locations

1

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Central trial contact

CZ Chen, PHD

Data sourced from clinicaltrials.gov

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