Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
NCT ID: NCT00901186
Last Updated: 2017-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2009-11-30
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
NONE
Study Groups
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RFB002
RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
RFB002
0.5 mg
Laser photocoagulation
At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
Laser photocoagulation
Interventions
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RFB002
0.5 mg
Laser photocoagulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
3. Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
4. Central foveal thickness \>250µm (Optical Coherence Tomography).
5. Diabetes medication stable in the 3 months prior.
Exclusion Criteria
1. Active intraocular inflammation.
2. Any active infection.
3. History of uveitis.
4. Structural damage within 500 microns of the center of the macula.
5. Neovascularization of the iris.
6. Uncontrolled glaucoma in either eye (Intraocular Pressure \> 24 mmHg).
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
Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis
Locations
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Novartis Investigative Site
Almería, Andalusia, Spain
Novartis Investigative Site
Cadiz, Andalusia, Spain
Novartis Investigative Site
Málaga, Andalusia, Spain
Novartis Investigative Site
Mallorca, Balearic Islands, Spain
Novartis Investigative Site
Barcelona, Barcelona, Spain
Novartis Investigative Site
Barcelona, Barcelona, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Barakaldo, Basque Country, Spain
Novartis Investigative Site
Valladolid, Castille and León, Spain
Novartis Investigative Site
Terrassa, Catalonia, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
Novartis Investigative Site
San Cristóbal de La Laguna, Las Palmas de Gran Canaria, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Pamplona, Navarre, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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Other Identifiers
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2009-010825-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRFB002DES01
Identifier Type: -
Identifier Source: org_study_id
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