The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with subfoveal CNV secondary to AMD as determined by the change in best-corrected visual acuity in the study eye from baseline to…
ID
Bron
Verkorte titel
Aandoening
eye; retina; age-related macular degeneration; choroidal neovascularization; angiogenesis; bevacizumab; ranibizumab; oog; retina; leeftijdsgebonden maculadegeneratie; Lucentis; Avastin
Ondersteuning
Department of Ophthalmology, Room A2-122
Academisch Medisch Centrum
Meibergdreef 9
1105 AZ Amsterdam
Tel +31205663616
e-mail: r.schlingemann@amc.uva.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the change in best-corrected visual acuity (BCVA) in the study eye from Baseline to Month 12 assessed with ETDRS-like VA charts at an initial distance of four meter.
Achtergrond van het onderzoek
The objective of this study is to compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab, given as monthly intravitreal injections during one year.
This will be a randomized, controlled, double masked, clinical trial in 306 patients in five academic trial centres in The Netherlands. The study population consists of patients 60 years of age or higher with primary or recurrent sub- or juxtafoveal CNV secondary to AMD with a total area of CNV of < 12 disc areas and a best corrected visual acuity BCVA score between 78 and 20 letters in the study eye. The primary outcome measure will be the change in best-corrected visual acuity (BCVA) in the study eye from Baseline to Month 12. Secondary outcomes will be amongst others the proportion of patients with a gain of 15 letters or more and/or a BCVA of 20/40 or more at 12 months, and the costs and costs per quality adjusted life-year of the two treatments
Doel van het onderzoek
The primary objective is to demonstrate the non-inferiority of bevacizumab to ranibizumab in the treatment of patients with subfoveal CNV secondary to AMD as determined by the change in best-corrected visual acuity in the study eye from baseline to month 12.
Onderzoeksopzet
1. 4 months;
2. 12 months.
Onderzoeksproduct en/of interventie
The included patient is randomized to receive either 1.25 mg bevacizumab or 0.5 mg ranibizumab.
Both investigational treatments will be administered by monthly intravitreal injection for one year (12 injections).
Publiek
Department of Ophthalmology, Room A2-122
Academisch Medisch Centrum
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663616/ +31 (0)20 5663682
r.schlingemann@amc.uva.nl
Wetenschappelijk
Department of Ophthalmology, Room A2-122
Academisch Medisch Centrum
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5663616/ +31 (0)20 5663682
r.schlingemann@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients 60 years of age or higher;
2. Patients with primary or recurrent sub-, juxta- or extrafoveal CNV secondary to AMD, including those with RAP, that may benefit from anti-VEGF treatment in the opinion of the investigator;
3. The total area of CNV (including both classic and occult components) encompassed within the lesion must be more or equal to 30% of the total lesion area;
4. The total lesion area should be < 12 disc areas;
5. A best corrected visual acuity (BCVA) score between 78 and 20 letters (approximately 0,63-0,05 Snellen equivalent) in the study eye.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Ocular treatment with anti-angiogenic drugs in the last 2 months or Triamcinolone in the last 6 months;
2. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline;
3. Patients with angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia;
4. Spherical equivalent of refractive error in the study eye demonstrating more than ¡V 8 dioptres of myopia;
5. Cataract extraction within three months preceding Baseline;
6. IOP >25 mm Hg;
7. Active intraocular inflammation in the study eye;
8. Vitreous haemorrhage obscuring view of the posterior pole in the study eye;
9. Presence of a retinal pigment epithelial tear involving the macula in the study eye;
10. Subretinal haemorrhage in the study eye if the size of the haemorrhage is > 70% of the lesion;
11. Subfoveal fibrosis or atrophy in the study eye;
12. History of hypersensitivity or allergy to fluorescein;
13. Inability to obtain fundus photographs, fluorescein angiograms or OCT¡¦s of sufficient quality to be analyzed and graded by the Central Reading Centre;
14. Systemic disease with a life expectancy shorter than the duration of the study;
15. Inability to adhere to the protocol with regard to injection and follow-up visits;
16. Legally incompetent adult;
17. Refusal to give written informed consent.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1621 |
| NTR-old | NTR1704 |
| Ander register | MEC AMC : 08-047 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |