check_circleStudy Completed
Eye Diseases
Bayer Identifier:
17867
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study for collection of Aflibercept data in Routine Practice
Trial purpose
The French CODEX study is designed as a national database to describe, in routine medical practice, functional and anatomical responses to intravitreal Aflibercept injection, in a large population of anti-VGEF-naïve patients presenting with wet Age-related Macular Degeneration (wAMD), Central Retinal Vein Occlusion (CRVO),Branch Retinal Vein Occlusion(BRVO), or Diabetic Macular Edema (DME). This national database will gather databases from French private and public ophthalmologic centers.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
425Trial Dates
September 2016 - November 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, France |
Primary Outcome
- Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.date_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).date_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) or converted to ETDRS.in each indicationdate_rangeTime Frame:Baseline and 6 month, 18 month and 24 monthenhanced_encryptionNoSafety Issue:
- Change in Central retinal thickness (CRT) as measured by Optical Coherence Tomography (OCT).in each indicationdate_rangeTime Frame:Baseline and 6 month, 18 month and 24 monthenhanced_encryptionNoSafety Issue:
- Number of injectionsin each indicationdate_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionNoSafety Issue:
- Interval (days) between injections per diseasein each indicationdate_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionNoSafety Issue:
- Presence of pigment epithelial detachment (PED) (Y/N)In wet age-related macular degeneration (wAMD) populationdate_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionYesSafety Issue:
- Proportion of patients with no fluid determined by OCT (absence of fluid includes all types of fluid and location of fluid as determined by the treating ophthalmologist)date_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionNoSafety Issue:
- Type of adjunctive therapies (ie focal laser, steroids etc.)date_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in score of diabetic retinopathy as determined by treating ophthalmologistIn Diabetic Macular Edema (DME) populationdate_rangeTime Frame:Baseline and 6 month, 12 month, 18 month and 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A