REGARD1: Diabetic Retinopathy Assessed by Ultra-wide

Sponsor

Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03157206

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema

Detailed Description

Diabetic retinopathy imaged by ultra wide field angiography (200°): the California (Optos, Scotland) allows ultrawide field pictures of 200° of the retina. This new imaging allows seeing beyond what was seen by the classic 7 ETDRS fields angiography:

In pivotal studies assessing the effect of antiVEGFs on diabetic retinopathy (DR) in patients treated for diabetic macular edema (DME), ETDRS DR classification was used based on the 7 classical ETDRS field fundus photographs. However, it has been identify that antiVEGF may modified the semiology (hemorrhages, micro-aneurisms) and consecutively modify the stage of DR. There is no assessment of the regression of peripheral ischemia of the retina (non perfused retina) by angiography during an antiVEGF treatment.
DR severity score (1) based on ETDRS classification assess the number of retinal lesions within the 7 classic retinal fields corresponding to around 30% of the total retina. It has been recently shown that peripheral lesions non visible on the classic 7 fields angiography could be predictive of progression of DR (2,3) at 4 years of follow-up independently of the initial stage of DR, HbA1C level, and could be new arguments for Laser treatment. This UWF imaging could help to understand some cases of patients with worst progression than expected, and to identify new therapeutic indications (4). These UWF pictures need to be explored in order to better characterize the severity of DR forms and probably find new therapeutics.

Impact of anti VEGF treatments on DR: pivotal studies assessing the efficacy of ranibizumab on DME explored also the effect of antiVEGFs on DR. One of the secondary endpoints of RISE and RIDE (5) studies, comparing the effect of ranibizumab 0.3mg versus 0.5mg versus sham injections, was the rate of new proliferative DR (PDR). This rate was of 33.8% in the sham group versus 11% in the treated group at 2 years of follow-up.

In Protocole I (6), the DRCRnet, found a 2 times lower risk to evolve toward PDR in case of ranibizumab treatment versus sham (7).

VIVID and VISTA showed at least 2 ETDRS steps improvement of DR for 30% of patients treated by aflibercept versus 8.2% to 15.6% at 2 years in the sham group.

It would be very interesting to have complementary data on improvement and worsening of DR under antiVEGF treatment with an angiographic analysis of the retinal periphery perfusion on larger field of the fundus than we usually have, and instead of color fundus photographs usually available in pivotal study to assess DR severity.

The purpose of this study is to characterize at one year the effect of aflibercept used for DME treatment on retinal periphery assessed by UWF angiography instead of the classic 7 ETDRS fields in order to quantify ischemia.

Study Design

Study Type:

Observational

Anticipated Enrollment :

49 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema

Actual Study Start Date :

Apr 19, 2017

Anticipated Primary Completion Date :

Jul 18, 2019

Anticipated Study Completion Date :

Sep 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
DME patients treated with aflibercept angiography by ultrawide field

Outcome Measures

Primary Outcome Measures

AntiVEGF effects on best visual acuity [12 months]
Retinian peripheral ischemia decrease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

History of treatment with any anti-VEGF agents within 12 months prior to inclusion
Application of any intra-vitreal treatment within 12 months prior to inclusion
Any aflibercept contraindication
History of panretinal photocoagulation laser (PRP)
Proliferative diabetic retinopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Giocanti-Auregan	Bobigny		France	93000

Sponsors and Collaborators

Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital

ClinicalTrials.gov Identifier:

NCT03157206

Other Study ID Numbers:

avoph_RNI_2016-001

First Posted:

May 17, 2017

Last Update Posted:

Jun 8, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Edema

Study Results

No Results Posted as of Jun 8, 2017