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RecruitingNCT04140448UWFA-RVO-MEUpdated Oct 18, 2023

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

An observational study in Retinal Vein Occlusion and Macular Edema, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Renmin Hospital of Wuhan University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Retinal Vein Occlusion
  • Macular Edema

Keywords

  • Ultra-wide field fundus fluorescein angiography
  • ischemic index
  • leakage index
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's planned enrollment of 60 is below the median of 97 across 163 observational studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chinese

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • UWFA-RVO-ME

    Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab

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

Interventions

  • DrugRanibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

    Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML

    Also known as: Lucentis, Anti-VEGF

  • DeviceUltra-wide Fluorescein Angiography

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and 1,2,3,4,6,9 and 12 months

  2. 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

    Time frame: Baseline and 1,2,3,4,6,9 and 12 months

Secondary outcomes

  1. Change in best corrected visual acuity

    Change in best corrected visual acuity from baseline to 1,2,3,4,6,9 and 12 months

    Time frame: Baseline and 1,2,3,4,6,9 and 12 months

  2. Change in central macular thickness

    Change in central macular thickness from baseline to1,2,3,4,6,9 and12 months

    Time frame: Baseline and 1,2,3,4,6,9 and 12 months

07

Study locations

1 of 1 sites recruiting
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei 430060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04140448
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Changzheng Chen (Chief of Department of Ophthalmology, Renmin Hospital of Wuhan University) — Principal investigator
First posted
Oct 25, 2019
Start date
Oct 9, 2023 (estimated)
Primary completion
Oct 30, 2024 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Oct 18, 2023

Study contacts

CZ Chen, PHD
Contact
whuchenchzh@163.com
+86 13072765173
CZ Chen, PHD
principal investigator · Renmin Hospital of Wuhan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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