Ultra-wide-field Fluorescein Angiography in Patients With... | NCT04075695

Studies
Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion

NCT04075695

Sponsor

Renmin Hospital of Wuhan University

Status

Unknown status

Last Update Posted

Oct 18, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Retinal Vein Occlusion

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2019Actual

Primary Completion Date

Dec 12, 2024Estimated

Completion Date

Aug 12, 2025Estimated

First Submitted Date

Aug 29, 2019

First Submission Date that Met QC Criteria

Aug 30, 2019

First Posted Date

Sep 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2023

Last Update Posted Date

Oct 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in best corrected visual acuity	Change in best corrected visual acuity from Baseline to 1，2，3，6，9and 12 months	Baseline and1，2， 3, 6, 9 and 12 months
Change in central macular thickness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive
Patient who agrees to participate to the study and who has given his/her written, informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Chinese

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CZ Chen, PHD	Contact	+86 13072765173		whuchenchzh@163.com
XL Wang	Contact	+86 13117192316		wangxl0807@163.com

Overall Officials

Name	Affiliation	Role
Renmin Hospital of Wuhan University	Renmin Hospital of Wuhan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renmin Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430000	China

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis