Phase IV study to evaluate the efficacy of aflibercept in subjects with neovascular age-related macular degeneration (wAMD), without optimal response to repeated monthly intravitreal injections of anti VEGF-A therapy.

• Conditions: Wet age-related macular degeneration; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-000848-26-ES
• Lead Sponsor: Barcelona Macula Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-11
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Men and women ? 50 years of age.
- Patients with any CNVM lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
- Patients with ETDRS best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
- Patients able to return for ALL clinic visits and complete all study-related procedures.
- Patients with absence of other ocular diseases that could affect visual acuity.
- Patients without optimal response to ranibizumab or bevacizumab defined as:
- Patient with significant persistent or recurrent fluid (intraretinal or ubretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 5 (+/- 1 week) after last treatment with ranibizumab or bevacizumab.
- Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three montly treatment with ranibizumab or bevacizumab.
- Patients who give their signed Informed Consent before any assessment and who expressly consent to the inclusion of their data in the medical history and those resulting from participation in the study in a file of personal data under the responsibility of the Centre.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

- Patients without scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Patients without RPE rip/tear involving the central fovea in the study eye.
- Patients with prior treatment with PDT
- Patients with prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
- Patients with intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
- Patients with history of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Patients with active intraocular inflammation in the study eye
- Patients with history of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Patients unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
- Potentially women who plan to become pregnant, are pregnant and / or breastfeeding, or who do not wish to use effective contraception (hormonal contraceptives [implementation, patches, oral], and double barrier methods [any double combination: IUDs, male or female prophylactics with spermicidal jelly, diaphragm, contraceptive sponge, cervical cap]).
- Patients who are participating in another simultaneous interventional clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified