EUCTR2014-000300-10-ES
Active, not recruiting
Phase 1
Phase IV study to evaluate the efficacy of aflibercept in naive patients with retinal angiomatous proliferation (RAP) lesions on an individualized ?Treat and Extend? (TAE) regimen. AFLIRAP Study. - AFLIRAP
Fundació Instituto de Investigación Biomédica de Bellvitge (Fundació IDIBELL)0 sitesApril 4, 2014
ConditionsRetinal angiomatous proliferation lesions (RAP)Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsEylea
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Retinal angiomatous proliferation lesions (RAP)
- Sponsor
- Fundació Instituto de Investigación Biomédica de Bellvitge (Fundació IDIBELL)
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?Signed Informed Consent
- •?Men and women ? 50 years of age.
- •? RAP lesions (stages I and II) with no previous treatment.
- •? ETDRS best\-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25\) in the study eye.
- •? BCVA \>20/400 in the fellow eye.
- •? Absence of significant cataract that could affect visual results.
- •? Able to return for ALL clinic visits and complete all study\-related procedures.
- •? Absence of other ocular diseases that could affect visual acuity.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •? Previous anti\-VEGF therapy, photodynamic therapy or thermal laser in the study eye.
- •? Recent cataract surgery (\<3 months) in the study eye.
- •? Any concurrent ocular disease that could affect the final outcome (diabetic retinopathy, advanced glaucoma, pathologic myopia).
- •? No scar, fibrosis, or atrophy involving the center of the fovea
- •? No RPE rip/tear involving the central fovea
- •? Participation in any other interventional clinical trial trial
- •? History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- •? Active intraocular inflammation in the study eye
- •? History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- •? Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
Outcomes
Primary Outcomes
Not specified
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