Percentage of patients showing regression of retinal neovascularization between baseline and month 12 in the Aflibercept group versus laser group MedDRA version: 18.1 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Eylea® 40mg/ml
Product Name: aflibercept
Pharmaceutical Form: Solution for injection
Sponsors
CHU DE POITIERS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetic patients with proliferative diabetic retinopathy - Aged 18 years old or more - Best corrected visual acuity score = 35 letters - Glycosylated hemoglobin rate =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Any history of retinal laser photocoagulation - Any history of intravitreal injection - Any history of vitrectomy - proliferative diabetic retinopathy associated to retinal detachment - proliferative diabetic retinopathy associated to fibrovascular proliferation - florid proliferative diabetic retinopathy - Allergy to fluorescein - Active infectious disease - Any significant recent (less than 3 months) cardiovascular disorder (angina pectoris, myocardial infarction, renal failure) - Any ocular disorder that could prevent retinal examination (cataract) - Significant macular edema =350 µm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of patients showing regression of retinal neovascularization between baseline and month 12 in the Aflibercept group versus laser group;Secondary Objective: Percentage of patients showing regression of retinal neovascularization between baseline and month 3 and 6 in the Aflibercept group versus laser group. - Variation of central macular thickness on SD-OCT between baseline months 3, 6 and 12. - Mean visual acuity variation (ETDRS score) between baseline and month 12. - Percentage of patients requiring vitrectomy for persistent intravitreal hemorrhage (more than 1 month) or retinal detachment at month 12 into the two groups. ;Primary end point(s): Percentage of patients showing regression of retinal neovascularization in the Aflibercept group versus laser group;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients showing regression of retinal neovascularization . - Variation of central macular thickness on SD-OCT - Mean visual acuity variation - Percentage of patients requiring vitrectomy for persistent intravitreal hemorrhage or retinal detachment ;Timepoint(s) of evaluation of this end point: -3, 6, 12 months | — |
Countries
France
Contacts
Public ContactFANNY ABRIAT
CHU DE POITIERS
Outcome results
None listed