Study, to evaluate the effectiveness of aflibercept in patients with RAP (retinal angiomatous proliferation) lesions.
- Conditions
- Retinal angiomatous proliferation lesions (RAP)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-000300-10-ES
- Lead Sponsor
- Fundació Instituto de Investigación Biomédica de Bellvitge (Fundació IDIBELL)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
? 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12-months (52 weeks).;Secondary Objective: ? Proportion of patients gaining 15 or more letters at 12-months <br>? Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks.<br>? Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks.<br>? Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks.<br>? Mean PED height change on SD-OCT scans at at 12 weeks & 52 weeks.<br>? Mean number of intravitreal injections.<br>? Percentage of patients only requiring mandatory doses<br>? Mean change of hypofluorescent areas on FAF (fundus autofluorescence) at 12-months.;Primary end point(s): Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12-months (52 weeks).;Timepoint(s) of evaluation of this end point: In week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Proportion of patients gaining 15 or more letters at 12-months <br>? Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks.<br>? Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks.<br>? Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks.<br>? Mean PED height change on SD-OCT scans at at 12 weeks & 52 weeks.<br>? Mean number of intravitreal injections.<br>? Percentage of patients only requiring mandatory doses<br>? Mean change of hypofluorescent areas on FAF (fundus autofluorescence) at 12-months.;Timepoint(s) of evaluation of this end point: Specified above