Retinal angiomatous proliferation lesions (RAP)
Conditions
Interventions
Trade Name: Eylea
Product Name: Eylea
Product Code: Eylea
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
Other descriptive name: AFLIBERCEPT
Concentration unit: mg millig
Sponsors
Fundació Instituto de Investigación Biomédica de Bellvitge (Fundació IDIBELL)
Eligibility
Sex/Gender
All
Inclusion 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: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ? Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks. ? Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks. ? Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks. ? Mean PED height change on SD-OCT scans at at 12 weeks & 52 weeks. ? Mean number of intravitreal injections. ? Percentage of patients only requiring mandatory doses ? 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Proportion of patients gaining 15 or more letters at 12-months ? Mean BCVA (best-corrected visual acuity) change (ETDRS letters) at 12 weeks. ? Mean foveal thickness change on SD-OCT (spectral domain optical coherence tomography) scans at 12 weeks & 52 weeks. ? Proportion of patients with no intraretinal/subretinal fluid on SD-OCT scans at 12 weeks & 52 weeks. ? Mean PED height change on SD-OCT scans at at 12 weeks & 52 weeks. ? Mean number of intravitreal injections. ? Percentage of patients only requiring mandatory doses ? Mean change of hypofluorescent areas on FAF (fundus autofluorescence) at 12-months.;Timepoint(s) of evaluation of this end point: Specified above | — |
Countries
Spain
Contacts
Public ContactElisabet Molina
Trial Form Support
Outcome results
None listed