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…
ID
Bron
Verkorte titel
Aandoening
neovascular age-related macular degeneration, natte leeftijdsgebonden maculadegeneratie
Ondersteuning
Radboud University Nijmegen Medical Centre, Ophthalmology Department
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
month 0: baseline + first injection
month 1: second injection
month 2: third injection
month 3: evaluation
Onderzoeksproduct en/of interventie
3 intravitreal injections of 2mg (0,05mL) aflibercept with monthly intervals
Publiek
F. Asten, van
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3610241
F.vanAsten@ohk.umcn.nl
Wetenschappelijk
F. Asten, van
Nijmegen 6525 EX
The Netherlands
+31 (0)24 3610241
F.vanAsten@ohk.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3974 |
| NTR-old | NTR4188 |
| CCMO | NL44122.091.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38763 |