Diabetic Retinopathy Assessed by Ultra-wide
REGARD1
Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema
1 other identifier
observational
49
1 country
1
Brief Summary
Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2017
CompletedFirst Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2020
CompletedJune 8, 2017
May 1, 2017
2.2 years
May 12, 2017
June 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
AntiVEGF effects on best visual acuity
Retinian peripheral ischemia decrease
12 months
Study Arms (1)
DME patients treated with aflibercept
angiography by ultrawide field
Eligibility Criteria
Diabetic patients (type 1 or 2) over 18 years of age with mild to severe non proliferative diabetic retinopathy and diabetic macular edema
You may qualify if:
- Male or female patients, ≥ 18 years
- type 1 or type2 diabetes mellitus
- patients with at least 1 eye with best corrected visual acuity (BCVA) between 24 and 78 ETDRS letters due to center-involved diabetic macular edema (DME). DME was defined by a central retinal thickness (CRT) \>300µm and the loss of foveal pit on SD-OCT
- Aflibercept treatment administred
- Afilliated to social security scheme
- agree to participate
You may not qualify if:
- Any aflibercept contraindication
- History of panretinal photocoagulation laser (PRP)
- Proliferative diabetic retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giocanti-Auregan
Bobigny, 93000, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 17, 2017
Study Start
April 19, 2017
Primary Completion
July 18, 2019
Study Completion
September 18, 2020
Last Updated
June 8, 2017
Record last verified: 2017-05