Neovascular Age-related Macular Degeneration
Conditions
Keywords
age-related macular degeneration, intravitreal injections, Aflibercept, EYLEA
Brief summary
This is a prospective, multicenter, single arm study. The study group will be compose of NVAMD patients who had partial or complete failure responding to initial bevacizumab or ranibizumab treatment of 3-6 monthly intravitreal injections. The patients in the study groups will receive 5 intravitreal injections of aflibercept 2mg/0.05ml at specific visits. Aflibercept will be provided for total period of 24 weeks.
Detailed description
The aim of this study is to prospectively evaluate the use of aflibercept in patients in whom initial incomplete response or loss of initial response for other intravitreal anti- vascular endothelial growth factor (anti-VEGF) therapy was demonstrated. This is a multi-center study initiated and conducted by the Israeli retina association. Each center participating in the study will follow the same protocol including standardized measurement of visual acuity, OCT, and Fluorescein angiography (FA). We will enroll 48 NVAMD patients which are partial or non-responded for 3-6 injections of intravitreal bevacizumab or ranibizumab and no more than one year of treatment . Test Treatment: Monthly intravitreal aflibercept 2mg /0.05 ml will be given at enrolment (day 0), 4 weeks, 8 weeks, 16 weeks, and 24 weeks after the initial enrollment for the study group. Follow-up period will be 28 weeks,7 visits. At the 28 week visit the primary and secondary end points will be evaluated.
Interventions
INTARAVITREAL INJECTION OF AFLIBERCEPT
Sponsors
Bayer
Hadassah Medical Organization
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
Ophthalmic Inclusion Criteria 1. Failure of previous intravitreal bevacizumab or ranibizumab treatment, defined as: * 3-6 intravitreal injections (The last 3 injections must be no more than 6 weeks between one injection to another). * Maximal central thickness by Heidelberg OCT has to be at least 300 microns or larger (retinal thickness including subretinal fluid {SRF},intraretinal fluid {IRF} and PED). 2. Subfoveal choroidal neovascularization (CNV) due to AMD as documented by fluorescein angiogram. 3. Best corrected visual acuity in the study eye between 20/40 and 20/360, inclusive. The VA must be re-confirmed at Day 0 prior to initiation of treatment. 4. Total area of the lesion (including blood, neovascularization, and scar/atrophy) must be ≤ 5 disc areas (DA), of which at least 50% must be active CNV. Active CNV is defined as the neovascular component of the lesion as defined by the fluorescein angiogram. 5. Presence on OCT of subretinal, intraretinal or sub-retinal pigment epithelial (RPE) fluid and/or subretinal thickening consistent with active CNV. 6. Clear ocular media and adequate pupillary dilatation 7. Intraocular pressure (IOP) of 21 mmHg or less. General Inclusion Criteria 1. Subjects of either gender, aged above 50 years. 2. Women should be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. 3. Provide written informed consent. 4. Ability to comply with study and follow-up procedures and return for all trial visits. \-
Exclusion criteria
Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central macular thickness change | at week 28 | Central macular thickness change from baseline on optical coherence tomography (OCT) at week 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity and Change in CNV size | at week 28 | 1. The mean change in best corrected ETDRS visual acuity at 4 meters according to a standardized protocol. 2. Gain or loss of 3-lines of visual acuity as defined above. 3. Change in CNV size according to fluorescein angiogram, following a standardized protocol. |
Other
| Measure | Time frame |
|---|---|
| Presence or intraretinal fluid, sub-retinal fluid, or pigment epithelial detachment . | at week 28 |
Countries
Israel
Outcome results
None listed