Wet Macular Degeneration
Conditions
Brief summary
Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.
Interventions
DRUG0.5mg aflibercept
0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.
Sponsors
TFS Trial Form Support
Bayer
Barcelona Macula Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent * Men and women ≥ 50 years of age. * Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration * Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye. * Able to return for ALL clinic visits and complete all study-related procedures. * 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 subretinal) 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 6 weeks 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 monthly treatment with ranibizumab or bevacizumab.
Exclusion criteria
* No scar, fibrosis, or atrophy involving the center of the fovea * No retina pigment epithelium (RPE) rip/tear involving the central fovea * Participation in another simultaneous interventional clinical trial * Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline * Prior treatment with photodynamic therapy (PDT) * Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline * 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 | Description |
|---|---|---|
| Percentage of patients with no fluid on Optical Coherence Tomography (OCT) after loading dose of aflibercept | Week 12 | At week 12 an OCT will be performed to evaluate the changes in intra or subretinal fluid and to determine the percentage of patients with no fluid after 3 doses of aflibercept injected on baseline visit, week 4 and week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in best corrected visual acuity (BCVA)after loading dose | week 12 | — |
| Changes in OCT central foveal thickness after loading dose | week 12 | — |
| Anatomic and Visual Acuity outcomes maintained during (every 8 weeks) treatment. | week 40 | — |
| Determine the time to resolution of any intra/sub retinal fluid on OCT | week 4,8,12,24,32,40 | — |
| Describe safety of this cohort of patients | baseline, week 4, 8, 12, 24, 32 and 40 | Describe the safety of aflibercept in study patients by determining ocular and non ocular adverse events classified according to type, frequency and severity during 40 weeks |
Countries
Spain
Outcome results
None listed