Switching to aflibercept in patients with neovascular AMD not responding to anti-VEGF treatment.

Phase 4

Completed

Conditions: age-related macular degeneration
macular degeneration
10047060

Registration Number: NL-OMON38763

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in central retinal thickness (µm) as measured on OCT between inclusion<br /><br>and one month after the 3 monthly aflibercept injections. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are change in visual acuity between inclusion and one month<br /><br>after the 3 monthly aflibercept injections, number of patients responding to<br /><br>aflibercept defined as a decrease in CRT of >50µm from inclusion compared to<br /><br>the last visit and number of patients gaining >5 letters of vision from<br /><br>inclusion compared to the last visit. </p><br>