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Overstappen op aflibercept bij patinten die niet reageren op anti-VEGF therapie


- candidate number15461
- NTR NumberNTR4188
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2013
- Secondary IDsNL44122.091.13 
- Public TitleOverstappen op aflibercept bij patinten die niet reageren op anti-VEGF therapie
- Scientific TitleSwitching to aflibercept in patients with neovascular age-related macular degeneration not responding to anti-VEGF treatment: a pilot study
- ACRONYMN/A
- hypothesisSince 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) studiedNeovascular age-related macular degeneration,
- Inclusion criteria- Patients with inadequate response to prior anti-VEGF treatment defined as a persistent central retinal thickness (CRT) of 300 m combined with a response of no greater than a reduction of 50 m 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 150m.
- 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate1-mei-2014
- Target number of participants20
- Interventions3 intravitreal injections of 2mg (0,05mL) aflibercept with monthly intervals
- Primary outcomeChange 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 >50m from inclusion compared to visit 5.
- Number of patients gaining >5 letters of vision from inclusion compared to visit 5.
- Timepointsmonth 0: baseline + first injection
month 1: second injection
month 2: third injection
month 3: evaluation
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. F. Asten, van
- CONTACT for SCIENTIFIC QUERIESDrs. F. Asten, van
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Bayer, NL
- PublicationsN/A
- Brief summaryCurrently, 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 300 m combined with a response of no greater than a reduction of 50 m 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 (m) as measured on OCT between inclusion and one month after the 3 monthly aflibercept injections.
- Main changes (audit trail)
- RECORD25-sep-2013 - 18-nov-2015


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