NCT04140448

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.

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 Oct 2023

Typical duration 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

October 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
4 years until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 24, 2019

Last Update Submit

October 17, 2023

Conditions

Retinal Vein OcclusionMacular Edema

Keywords

Ultra-wide field fundus fluorescein angiographyischemic indexleakage index

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in best corrected visual acuity

    Baseline and 1,2,3,4,6,9 and 12 months

  • Change in central macular thickness

    Baseline and 1,2,3,4,6,9 and 12 months

Study Arms (1)

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

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]DRUG

Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML

Also known as: Lucentis, Anti-VEGF
UWFA-RVO-ME
Ultra-wide Fluorescein AngiographyDEVICE

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

UWFA-RVO-ME

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 older
  • Macular edema secondary to CRVO,BRVO or HRVO
  • Duration of RVO not more than 4 months
  • Patient who agrees to participate in 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, 430060, China

RECRUITING

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • CZ Chen, PHD

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CZ Chen, PHD

CONTACT

+86 13072765173whuchenchzh@163.com

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

October 24, 2019

First Posted

October 25, 2019

Study Start

October 9, 2023

Primary Completion

October 30, 2024

Study Completion

December 15, 2025

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

CN(1)