Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial. - Anti-VEGF versus RPE-choroid graft

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2008-008259-41-NL
• Lead Sponsor: Rotterdam Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-11
• Study Completion: 2011-08-26
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 (< 3 months) activity of the lesion
(i.e. recent haemorrhage, change of lesion compared to previous examination, deterioration of VA, scotoma or metamorphopsia)
- myopia < -8 D
- clear media to permit fundus photography, FAG, ICG-A and OCT
- capable to follow instructions
- willing and physically able to complete study visits during at least 12 months
- anticoagulant drugs (Coumarin, antiplatelet agents) can be discontinued during 6 weeks

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>- To determine quality of life (VFQ-25 questionnaire).<br>- 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.<br>- Foveal fixation <br>- 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.<br>