Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT ID: NCT01217944
Last Updated: 2014-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
277 participants
INTERVENTIONAL
2010-10-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ranibizumab driven by disease activity
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
Ranibizumab
0.5 mg ranibizumab intravitreal injection
Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Ranibizumab driven by stabilization criteria
Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
Ranibizumab
0.5 mg ranibizumab intravitreal injection
Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
Ranibizumab
0.5 mg ranibizumab intravitreal injection
Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Interventions
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Ranibizumab
0.5 mg ranibizumab intravitreal injection
Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
* High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia
* Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal
Exclusion Criteria
* Blood pressure \> 150/90 mmHg
* History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
* Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Vienna, Austria, Austria
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Linz, Upper Austria, Austria
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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Bordeaux, France, France
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Dijon, , France
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Paris, , France
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Reims, , France
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Toulouse, , France
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Berlin, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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München, , Germany
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Münster, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Regensburg, , Germany
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Hong Kong, Hong Kong, Hong Kong
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Budapest, , Hungary
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Debrecen, , Hungary
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Mumbai, Maharashtra, India
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New Delhi, New Delhi, India
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Chennai, Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Bangalore, , India
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Bari, BA, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Udine, UD, Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Fukushima, Fukushima, Japan
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Sapporo, Hokkaido, Japan
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Kita-gun, Kagawa-ken, Japan
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Kyoto, Kyoto, Japan
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Matsumoto, Nagano, Japan
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Hirakata, Osaka, Japan
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Suita, Osaka, Japan
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Bunkyo-ku, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Riga, , Latvia
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Bielsko-Biala, , Poland
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Coimbra, , Portugal
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Porto, , Portugal
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Singapore, Singapore, Singapore
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Singapore, Singapore, Singapore
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Singapore, , Singapore
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Banská Bystrica, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Bilbao, Basque Country, Spain
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Valladolid, Castille and León, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Alicante, Valencia, Spain
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Bern, , Switzerland
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Ankara, Turkey, Turkey (Türkiye)
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Ankara, Turkey, Turkey (Türkiye)
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Etlik / Ankara, , Turkey (Türkiye)
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Belfast, , United Kingdom
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Bristol, , United Kingdom
Novartis Investigative Site
Wolverhampton, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-021662-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002F2301
Identifier Type: -
Identifier Source: org_study_id
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