Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
NCT ID: NCT01840410
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
183 participants
INTERVENTIONAL
2013-09-30
2015-11-30
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
A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Sham control
Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
Sham control
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
Interventions
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Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Sham control
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
Eligibility Criteria
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Inclusion Criteria
* BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
* Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
Exclusion Criteria
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* CNV- conditions with a high likelihood of spontaneous resolution;
* History of intravitreal treatment with steroids;
* History of laser photocoagulation;
* History of intraocular treatment with any anti-angiogenic drugs.
12 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
Sydney, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
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South Launceston, Tasmania, Australia
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Montreal, Quebec, Canada
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Hradec Králové, , Czechia
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Prague, , Czechia
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Glostrup Municipality, , Denmark
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Paris, France, France
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Paris, , France
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Leipzig, Germany, Germany
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Regensburg, Germany, Germany
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Bochum, , Germany
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Bonn, , Germany
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Düsseldorf, , Germany
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Freiburg I. Br, , Germany
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Münster, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Pátrai, Greece, Greece
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Thessaloniki, Greece, Greece
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Heraklion Crete, GR, Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Bari, BA, Italy
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Catania, CT, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Udine, UD, Italy
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Varese, VA, Italy
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Riga, , Latvia
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Kaunas, LTU, Lithuania
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Vilnius, , Lithuania
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San Isidro, Lima region, Peru
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Katowice, , Poland
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Wroclaw, , Poland
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Coimbra, Portugal, Portugal
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Porto, Portugal, Portugal
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Singapore, , Singapore
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Banská Bystrica, Slovakia, Slovakia
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Trenčín, Slovakia, Slovakia
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Busan, Busan, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Seoul, South Korea
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Málaga, Andalusia, Spain
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Valladolid, Castille and León, Spain
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Sant Cugat del Vallès, Catalonia, Spain
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Bern, , Switzerland
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Binningen, , Switzerland
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Lausanne, , Switzerland
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Kocaeli, , Turkey (Türkiye)
Countries
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Other Identifiers
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2012-005417-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002G2301
Identifier Type: -
Identifier Source: org_study_id
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