Wet age-related macular degeneration
Conditions
Interventions
Trade Name: Eylea
Product Name: Eylea
Product Code: Eylea
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
Current Sponsor code: AFLIBERCEPT
Other descriptive name: AFLIBER
Sponsors
Barcelona Macula Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy of aflibercept treatment of wAMD patients without optimal response to anti VEGF-A therapy, in terms of the percentage of patients with no fluid on OCT after loading dose (intra or subretinal) of aflibercept (3 initial monthly doses).;Secondary Objective: - Mean change in visual acuity (BCVA) after loading dose at 12 weeks - Mean change in OCT central foveal thickness after loading dose at 12 weeks - Anatomic outcomes maintained during the treatment (administrated every 8 weeks) at week 40, in central retinal thickness and VA outcomes maintained during the treatment (administrated every 8 weeks) at week 40, in terms of BCVA. - Time to resolution of any intra/subretinal fluid on OCT - Describe safety of aflibercept in this studied population according to ocular and non-ocular adverse events (AE), characterized by: type, frequency, relation and severity, during the 40 weeks.;Primary end point(s): Percentage of patients with no fluid on OCT after 3 loading doses of VEGF Trap-Eye (week 12).;Timepoint(s) of evaluation of this end point: In week 12 after 3 loading doses of VEGF Trap-Eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean change in BCVA at week 12 measured by ETDRS Scale - Percentage of patients with no fluid on OCT at week 40. - Mean change in BCVA at week 40 measured by ETDRS Scale - Time to no fluid on OCT;Timepoint(s) of evaluation of this end point: Week 12 and week 40 depending of the end point. Specified above | — |
Countries
Spain
Contacts
Public ContactElisabet Molina
Trial Form Support
Outcome results
None listed