To examine features of treatment response on optical coherence tomography in patients who were switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in central retinal thickness (µm) as measured on OCT between inclusion
and one month after the 3 monthly aflibercept injections.
Secondary outcome
Secondary endpoints are change in visual acuity between inclusion and one month
after the 3 monthly aflibercept injections, number of patients responding to
aflibercept defined as a decrease in CRT of >50µm from inclusion compared to
the last visit and number of patients gaining >5 letters of vision from
inclusion compared to the last visit.
Background summary
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 in 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 little
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 objective
To examine features of treatment response on optical coherence tomography in
patients who were switched to aflibercept after non-response to previous
intravitreal anti-VEGF treatment.
Study design
Prospective interventional case series pilot study.
Intervention
Patients will be treated with 3 monthly intravitreal injections of 2mg (0,05mL)
aflibercept.
Study burden and risks
During inclusion patients receive an ophthalmic examinatiom and visual acuity
measurement. A fluorescein angiography (FA) and OCT-scan will be performed to
confirm the diagnosis of active neovascular AMD. The FA requires intravenous
access to administer the fluorescein dye. After inclusion patients are
scheduled to receive 3 intravitreal injections with aflibercept with 4 week
intervals performed by a trained physician. The first injection will take place
within 2 weeks after inclusion. Before the second and third injection an
OCT-scan and ophthalmic examination is performed as an additional insurance of
safety. One month after the last injection patients will return for an
evaluation visit which includes an OCT-scan, visual acuity measurements and
ophthalmic examination. Risks in the course of this study are related to
receiving intravitreal injections. Serious adverse events are comparable to
other intravitreal anti-VEGF injections, namely endophthalmitis, retinal
detachment, increased intraocular pressure and a potentially increased risk of
thromboembolic events. However, patients may also profit from this study, as
they get the opportunity to receive treatment that may prove to be beneficial,
especially since other treatment had not been effective.
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Philips van Leydenlaan 15
Nijmegen 6525EX
NL
Listed location countries
Age
Inclusion criteria
- Patients with neovascular age-related macular degeneration (AMD) that have shown inadequate response to anti-VEGF treatment, defined as a persistant central retinal thickness on optical coherence tomography (OCT) of >=300 µm combined with a response of no greater than a reduction of 50 µm 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 fluoresceine angiography 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 >=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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-001208-12-NL |
| CCMO | NL44122.091.13 |
| OMON | NL-OMON19994 |