drugset / Trial / NCT01217944
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
Timeline
- Start
- 2010-10
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Met primary endpoint
paper Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 PMID 24326106 ↗
paper group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both P<0.0001 PMID 24326106 ↗
Publications
- Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8. No abstract available.
- Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |
| Comparator | Verteporfin | Other / unclassified | 6 mg/m2 | Intravenous |