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Avastin-Injections in Age Related Macular Degeneration:
Prospective Study for Optimal Frequency and Follow-up Determination.



- candidate number2987
- NTR NumberNTR1174
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2008
- Secondary IDsOZR-2007-06 Oogziekenhuis Rotterdam, Schiedamsevest 180, 3011 BH Rotterdam
- Public TitleAvastin-Injections in Age Related Macular Degeneration:
Prospective Study for Optimal Frequency and Follow-up Determination.
- Scientific TitleAvastin-Injections in Age Related Macular Degeneration:
Prospective Study for Optimal Frequency and Follow-up Determination.
- ACRONYMN/A
- hypothesisThe Avastin injection schedule for ARMD can be optimized.
- Healt Condition(s) or Problem(s) studiedAge Related Macular Degeneration (ARMD)
- Inclusion criteria1. Informed consent;
2. Endophthalmitis risks have been made clear;
3. No preference to participate in the Infliximab for ARMD trial;
4. Age ˇÝ 65 years;
5. Exudative subfoveolar age related macular degeneration;
6. No significant other ocular disorders affecting visual acuity;
7. Not immunocompromised;
8. No allergy for fluorescein or ICG dye injections;
9. No treatment for ARMD or other retinal problem in the 3 months prior to trial start;
10. No planned ocular surgery in the first year after trial start.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate31-dec-2009
- Target number of participants360
- InterventionsIntravitreal injection of Avastin (1.25 mg in 0.05 ml ).
- Primary outcome1. Visual acuity (in lines lost or gained) at 6 months and 1 year;
2. OCT outcomes at 6 months and 1 year.
- Secondary outcomeIncidence of endophthalmitis and other side effects.
- TimepointsBaseline, 6 months and 1 year.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES T. Missotten
- CONTACT for SCIENTIFIC QUERIES T. Missotten
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsLushchyk T, Amarakoon S, Martinez-CirianoJP, van den Born LI, Baarsma GS, Missotten T. Bevacizumab in age-related macular degeneration: a randomized controlled trial on the effect of injections every 4 weeks, 6 weeks and 8 weeks. Acta Ophthalmol. 2013; 91(6): e456-461. PMID: 23773796
- Brief summaryRationale:
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.


Objective:
To determine the optimal patient observation and Avastin injection schedule. Study design: Prospective, open-label, randomized.


Study population:
Patients with exudative ARMD


Intervention:
Intravitreal Avastin injection.


Main study parameters/endpoints:
Visual acuity at 12 months. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
- Main changes (audit trail)
- RECORD8-jan-2008 - 12-sep-2014


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