|- candidate number||15461|
|- NTR Number||NTR4188|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-sep-2013|
|- Secondary IDs||NL44122.091.13 |
|- Public Title||Overstappen op aflibercept bij patiënten die niet reageren op anti-VEGF therapie|
|- Scientific Title||Switching to aflibercept in patients with neovascular age-related macular degeneration not responding to anti-VEGF treatment: a pilot study|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Neovascular age-related macular degeneration, |
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-mei-2014|
|- Target number of participants||20|
|- Interventions||3 intravitreal injections of 2mg (0,05mL) aflibercept with monthly intervals|
|- 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.
|- Timepoints||month 0: baseline + first injection|
month 1: second injection
month 2: third injection
month 3: evaluation
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. F. Asten, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. F. Asten, van|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||25-sep-2013 - 18-nov-2015|