To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
NCT ID: NCT01846299
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
181 participants
INTERVENTIONAL
2013-10-31
2015-09-30
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 switched 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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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.
Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Eligibility Criteria
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Inclusion Criteria
* BCVA must be between ≥ 24 and ≤ 83 letters;
* Visual loss should be mainly due to the presence of any eligible types of ME.
Exclusion Criteria
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* Any type of advanced, severe or unstable ocular disease or its reatment;
* ME with a high likelihood of spontaneous resolution.
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
Westmead, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
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Hobart, Tasmania, Australia
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South Launceston, Tasmania, Australia
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Leuven, , Belgium
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Halifax, Nova Scotia, Canada
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Pilsen, , Czechia
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Prague, , Czechia
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Bordeaux, France, France
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Lyon, , France
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Paris, , France
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Saint-Jean, , France
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Leipzig, Germany, Germany
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Regensburg, Germany, Germany
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Düsseldorf, , Germany
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Freiburg I. Br, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Florence, FI, Italy
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Genova, GE, Italy
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Milan, MI, Italy
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Pisa, PI, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Riga, , Latvia
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Tilburg, Netherlands, Netherlands
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Amsterdam, , Netherlands
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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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L'Hospitalet de Llobregat, Barcelona, Spain
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Valladolid, Castille and León, Spain
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Sant Cugat del Vallès, Catalonia, Spain
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Zurich, Switzerland, Switzerland
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Bern, , Switzerland
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Binningen, , Switzerland
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Ankara, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Frimley, Surrey, United Kingdom
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London, United Kingdom, United Kingdom
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Birmingham, , United Kingdom
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Bristol, , United Kingdom
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Manchester, , United Kingdom
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Southampton, , United Kingdom
Novartis Investigative Site
Sunderland, , United Kingdom
Countries
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Other Identifiers
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2012-005418-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002G2302
Identifier Type: -
Identifier Source: org_study_id
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