Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
49 participants
OBSERVATIONAL
2017-04-19
2020-09-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
NCT02151695
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
NCT02874859
Shanghai Beixinjing Diabetic Eyes Study
NCT03571217
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema
NCT02441907
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
NCT02924311
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DME patients treated with aflibercept
angiography by ultrawide field
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Application of any intra-vitreal treatment within 12 months prior to inclusion
* Any aflibercept contraindication
* History of panretinal photocoagulation laser (PRP)
* Proliferative diabetic retinopathy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Giocanti-Auregan
Bobigny, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
avoph_RNI_2016-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.