To determine the optimal patient observation and Avastin injection schedule.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual acuity at 12 months.
OCT outcomes at 12 months.
Secondary outcome
Endophthalmitis and other side effects frequency.
Background summary
Age-related macular degeneration (ARMD) results in a deterioration of the
central retinal function, and is the leading cause of blindness in people over
50 years of age in Europe and the USA. The wet form of ARMD, with choroidal
neovascularization, is more aggressive and may progress more rapidly to
blindness. Recently, Lucentis® has been registered for treatment of wet ARMD,
but is (as yet) not reimbursed by health care insurance. Avastin® appears to be
a cost-effective alternative for Lucentis®, but an optimal injection schedule
has not been determined so far. A reduction of the number of injections,
without loss of treatment efficacy, would have a number of beneficial effects:
a decrease of the risk associated with intravitreal injection (such as
endophthalmitis), cost-effectiveness and reduced ophthalmic work-load.
Study objective
To determine the optimal patient observation and Avastin injection schedule.
Study design
Prospective, open-label, randomized.
Intervention
Intravitreal Avastin injection.
Study burden and risks
Avastin appears to be a promising off-label treatment for exudative ARMD and
would provide a cheap alternative to Lucentis. It is FDA and EMEA approved for
colorectal tumor treatment adjuvans, and has been shown to be safe for
intravitreal use in short term animal and human trials. Repeated injections
pose a (cumulative) risk of endophthalmitis, but prognosis for untreated
exudative ARMD is very poor.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Informed consent
- Endophthalmitis risks have been made clear
- No preference to paritcipate in the Infliximab for ARMD trial
- Age >= 65 years
- Exudative subfoveolar age related macular degeneration
- No significant other ocular disorders affecting visual acuity
- Not immunocompromised
- No allergy for fluorescein or ICG dye injections
- No treatment for ARMD or other retinal problem in the 3 months prior to trial start
- No planned ocular surgery in the first year after trial start
Exclusion criteria
- Use of coumarin-derivatives at the time of inclusion
- Clinical significant CVA or MCI in the 6 months prior to planned inclusion
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 | EUCTR2007-003766-17-NL |
| CCMO | NL18584.078.07 |