NL-OMON38763
Completed
Phase 4
Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment. - Switching non-responders to aflibercept.
niversitair Medisch Centrum Sint Radboud0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- age-related macular degeneration
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with neovascular age\-related macular degeneration (AMD) that have shown inadequate response to anti\-VEGF treatment, defined as a persistant central retinal thickness on optical coherence tomography (OCT) of \>\=300 µm combined with a response of no greater than a reduction of 50 µm after each previous intravitreal anti\-VEGF treatment.;\- Patients will have received at least 6 anti\-VEGF injections within 1 year. ;\- Active neovascular AMD seen as leakage on fluoresceine angiography and (sub\-) retinal fluid on OCT. ;\- Maximally 1 year since onset of visual complaints and start of anti\-VEGF treatment. ;\- Minimally 1 month and maximally 3 months between last anti\-VEGF injection and first aflibercept injection. ;\- Age 50 years and older;\- Visual acuity at baseline between 20/25 and 20/320 (Snellen). ;\- OCT available prior to first injection and after every three anti\-VEGF injections.;\- Give written informed consent.
Exclusion Criteria
- •\- Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula.;\- Pigment epithelial detachment with a height of \>\=150µm. ;\- Any ocular diseases beside AMD in the study eye, including myopic fundus and vitreoretinal traction. ;\- Myopia of 8\.00 D or more, irrespective of myopic fundus features. ;\- Ocular surgery of the study eye \<\= 2 months prior to or during the previous anti\-VEGF treatment.
Outcomes
Primary Outcomes
Not specified
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