The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25 mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months for the treatment of macular edema secondary to a retinal vein occlusion.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the mean change in best corrected visual acuity
after 6 months compared to baseline.
Secondary outcome
Amongst others:
The proportion of patients with a decrease of the best corrected visual acuity
less than 15 letters on the EDTRS chart at 6 months compared to baseline.
The proportion of patients with a decrease of the best corrected visual avuity
of 15 letters or more on the EDTRS chart at 6 months compared to baseline.
For the full listings we refer to the protocol chapter 7.1 study endpoints
Background summary
Ranibizumab (Lucentis), a VEGF inhibitor, is registered for the use of
intravitreal treatment of age-related macular degeneration (AMD) and meant a
breakthrough for the treatment of these patients. Recently, it will also be
registered for the intravitreal treatment of macular edema secondary to retinal
vein occlusions (RVO). The therapy has also shown good results for this
condition.
The comparable product bevacuzimab (Avastin) is registered for the systemic
treatment of patients with metastasized colorectal carcinoma but has been used
in an off-label setting in ophthalmology for the intravitreal treatment of AMD
and macular edema secondary to a retinal vein occlusion.
The treatment with bevacizumab is much cheaper than the treatment with
ranibizumab. The efficacy and safety of bevacizumab has been studied in
case-series and internet based patient registries only, but a directly
comparative study for this indication has not yet been published. The general
impression is that both products are equally effective.
Study objective
The goal of the trial is to compare the efficacy and costs of bevacizumab 1.25
mg and ranibizumab 0.5mg given as monthly intravitreal injections over 6 months
for the treatment of macular edema secondary to a retinal vein occlusion.
Study design
It is a comparative, randomised, double masked study.
Intervention
Bevacizumab 1.25 mg and ranibizumab 0.5mg are administered as monthly
intravitreal injections for 6 months to patients with macular edema secondary
to a retinal vein occlusion.
During the study visual acuity will be measured, safety assessments, optical
coherence tomography and fluorescein angiography will be performed and a
questionnaire concerning the costs should be filled in.
Study burden and risks
In this trial patients will receive in total 6 intravitreal injections
according to a fixed schedule. In the regular treatment in the first 6 months
3-6 injections are administered in a variable schedule depending on the
evolution of the disease. Hence in some cases, study patients will receive more
injections than in the regular treatment. This is done in order to compare the
maximal effect of both products after 6 months. For each intravitreal injection
there is a risk of around 0.05% to develop an endophtalmitis; because of the
higher increase in number of injections, this risk is slightly higer for study
patients than for the regular treament.
Besides there are possibly unkown risks for the ophthalmological treatment with
bevacizumab which is not registered for the treatment of macula edema secondary
to retinal vein occlusion.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Male or female patients > 18 years of age with recent vision loss due to foveal center-involved ME secondary to branch or central retinal vein occlusion who, in the opinion of the investigator, could have functional benefit from injections with a VEGF antagonist, and who have signed an informed consent.
* BCVA > 24 and < 78 letters in the study eye and, inclusively, using ETDRS- like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening.
* Mean central subfield thickness > 275 µm from 2 OCT measurements
Exclusion criteria
see also protocol 4.4
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-003277-29-NL |
| CCMO | NL35869.018.11 |