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.
- Conditions
- age-relatede macular degeneration10047060
- Registration Number
- NL-OMON33994
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- informed consent
- age >= 65 years
- AMD in combination with either of the following conditions:
1 visual loss of >= 15 letters on the ETDRS chart after 3 anti-VEGF injections,
2 subfoveal RPE-tear,
3 massive submacular haemorrhage.
- visual acuity of 20/63 to 20/800.
- recent (< 3 months) activity of the lesion
- myopia < -8 D
- clear media to permit fundus photography, FAG, ICG-A and OCT
- capable to follow instructions
- anticoagulant drugs can be discontinued during 6 weeks
- haemorrhage or PED secondary to:
1 retinal angiomatous proliferation,
2 aneurysm,
3 CNV associated with high myopia,
4 polypoidal choriodopathy.
- 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.
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Visual acuity, reading vision and foveal fixation at 1 years.</p><br>
- Secondary Outcome Measures
Name Time Method <p>VA and reading vision at 2 years.<br /><br>IOP.</p><br>