NCT04075695

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

5.2 years

First QC Date

August 29, 2019

Last Update Submit

October 17, 2023

Conditions

Keywords

ischemic indexUltra-wide field fundus fluorescein angiographyvascular leakage index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in best corrected visual acuity

    Baseline and1,2, 3, 6, 9 and 12 months

  • Change in central macular thickness

    Baseline and1,2, 3, 6, 9 and 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese

You may qualify if:

  • Male or female aged 18 years or more
  • Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
  • Duration of RVO not more than 4 months
  • Patient who agrees to participate to the study and who has given his/her written, informed consent

You may not qualify if:

  • 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
  • Active or suspected ocular or periocular infection
  • Active severe intraocular inflammation
  • RVO complicated with neovascularization
  • Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
  • Patient already included in the study for the treatment of the fellow eye
  • Pregnant or breastfeeding woman
  • Lack of effective contraception for women of childbearing age
  • Patient taking part in an interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Renmin Hospital of Wuhan University

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Ophthalmology

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 3, 2019

Study Start

September 18, 2019

Primary Completion

December 12, 2024

Study Completion

August 12, 2025

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations