No registrations found.
ID
Source
Brief title
Health condition
neovascular age-related macular degeneration, natte leeftijdsgebonden maculadegeneratie
Sponsors and support
Radboud University Nijmegen Medical Centre, Ophthalmology Department
Intervention
Outcome measures
Primary outcome
Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections
Secondary outcome
- Change in visual acuity between inclusion and one month after 3 monthly aflibercept injections.
- Number of patients responding to aflibercept defined as a decrease in CRT of >50¦Ìm from inclusion compared to visit 5.
- Number of patients gaining >5 letters of vision from inclusion compared to visit 5.
Background summary
Currently, when patients with neovascular age-related macular degeneration (AMD) do not respond to bevacizumab, patients often switch to ranibizumab, which has a comparable working mechanism. Switching to ranibizumab has so far yielded limited additional effect. Recently, a new VEGF-inhibitor aflibercept (Eylea) has arrived, with a different mechanism of action. Patients that do not respond to other anti-VEGF agents, may show a good response to aflibercept.
This prospective interventional case series pilot study will inlcude 20 patients with neovascular AMD who did not respond to previous anti-VEGF therapy defined as: persistant central retinal thickness on optical coherence tomography (OCT) of ¡Ý300 ¦Ìm combined with a response of no greater than a reduction of 50 ¦Ìm after each previous intravitreal anti-VEGF treatment. Patients will be treated with 3 monthly intravitreal injections of 2mg (0,05mL) aflibercept. The primary outcome is change in central retinal thickness (¦Ìm) as measured on OCT between inclusion and one month after the 3 monthly aflibercept injections.
Study objective
Since several years, anti-VEGF agents have become available for the treatment of neovascular age-related macular degeneration (AMD) and have substantially improved visual prognosis in patients suffering from this condition. The anti-VEGF agent used most frequently world-wide is bevacizumab (Avastin). The effectiveness and working mechanism of bevacizumab is comparable to ranibizumab (Lucentis). Even though many patients have benefitted from these anti-VEGF agents, still 10% of patients do not respond to treatment and experience a loss of vision comparable to the natural course of AMD. These patients are considered non-responders. Currently, when patients do not respond to bevacizumab, patients often switch to ranibizumab, which has a comparable working mechanism. Switching to ranibizumab has so far yielded limited additional effect. Recently, a new VEGF-inhibitor aflibercept (Eylea) has arrived, with a different mechanism of action. Patients that do not respond to other anti-VEGF agents, may show a good response to aflibercept.
Study design
month 0: baseline + first injection
month 1: second injection
month 2: third injection
month 3: evaluation
Intervention
3 intravitreal injections of 2mg (0,05mL) aflibercept with monthly intervals
F. Asten, van
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3610241
F.vanAsten@ohk.umcn.nl
F. Asten, van
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3610241
F.vanAsten@ohk.umcn.nl
Inclusion criteria
- Patients with inadequate response to prior anti-VEGF treatment defined as a persistent central retinal thickness (CRT) of ¡Ý300 ¦Ìm combined with a response of no greater than a reduction of 50 ¦Ìm in CRT on OCT 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 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 (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 ¡Ý150¦Ìm.
- 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 ¡Ü 2 months prior to or during the previous anti-VEGF treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3974 |
| NTR-old | NTR4188 |
| CCMO | NL44122.091.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38763 |