Switching to aflibercept in patients with wet AMD not responding to anti-VEGF treatment.
- Conditions
- eovascular Age-related macular degenerationTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-001208-12-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
- Patients will have received at least 6 anti-VEGF injections within 1 year.
- Active neovascular AMD seen as leakage on FA 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.
- OCT available prior to first injection and after every three anti-VEGF injections.
- Give written informed consent.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula.
- Pigment epithelial detachment with a maximum 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to examine features of treatment response on optical coherence tomography in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. ;Secondary Objective: To examine change in visual acuity in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment.<br>To evaluate the number of patients responding to aflibercept. <br>To evaluate the number of patients gaining >5 letters of visual acuity from inclusion to study end. <br>;Primary end point(s): Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections.;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): o Change in visual acuity between inclusion and one month after 3 monthly aflibercept injections.<br>o Number of patients responding to aflibercept defined as a decrease in CRT of >50µm from inclusion compared to visit 5. <br>o Number of patients gaining >5 letters of vision from inclusion compared to visit 5. <br>;Timepoint(s) of evaluation of this end point: At baseline and after 3 months.