Age related macular degeneration and either of the following conditions: 1) not responding to 3 intravitreal anti-VEGF injections, or 2) pigment epithelium rip, or 3) massive haemorrhage.
Conditions
Interventions
Trade Name: NA
Product Name: RPE-choroid graft
Product Code: NA
Pharmaceutical Form:
Trade Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Rotterdam Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - informed consent - age = 65 years - AMD in combination with either of the following conditions: - visual loss of = 15 letters on the ETDRS chart after 3 anti-VEGF injections, - subfoveal RPE-tear, - massive submacular haemorrhage (i.e. extending beyond the vascular arcades, subfoveal thickness of 1.5 mm (ultrasonography), and no subfoveal red blood. - visual acuity of 20/63 to 20/800. - history or examination must indicate recent (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - haemorrhage or PED secondary to: - retinal angiomatous proliferation - aneurysm - CNV associated with high myopia - polypoidal choriodopathy - known hypersensitivity to humanized monoclonal antibodies - current acute ocular or peri-ocular infection - any major surgical procedure (scheduled) within 1 month of study entry not related to this study, cataract surgery excepted. - known serious allergy to fluorescein or indocyanine green dye - significant other ocular disorders affecting visual acuity - immunocompromised - current treatment for active systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare visual outcome (distance and reading) and foveal fixation (biomicroscopy, microperimetry) of RPE-choroid graft translocation versus intravitreal anti-VEGF therapy at 12 and 24 months.;Secondary Objective: - To compare safety of both treatments. - To determine quality of life (VFQ-25 questionnaire). - To demonstrate whether complement factor-H (CFH) polymorphism correlates with visual ;Primary end point(s): - Visual acuity (lines lost or gained on ETDRS chart) at one year after initial treatment. - Foveal fixation - Reading vision (in Austria, Germany and The Netherlands, the Radner chart will be used; in France and Italy the Parinaud chart; in London Jaeger chart) at one year. | — |
Countries
Netherlands
Outcome results
None listed