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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00901186 |
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Date of registration:
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11/05/2009 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
RED-ES |
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Scientific title:
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A Randomized, Open Label, Multicenter, Laser-controlled Phase II Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) vs. Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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84 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00901186 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic
Macular Edema in at least one eye.
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:
In the study eye:
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).
Other protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetic Macular Edema
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Visual Impairment
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Intervention(s)
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Drug: Ranibizumab
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Procedure: Laser
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Primary Outcome(s)
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Change Best Corrected Visual Acuity with ranibizumab 0.5 mg vs laser 12-month.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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% of patients with Visual Acuity > 73 letters with ranibizumab (0.5 mg) vs Laser.
[Time Frame: 4 weeks]
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Improvement in Best Corrected Visual Acuity with ranibizumab (0.5 mg) vs laser 12-month Measure
[Time Frame: 4 weeks]
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Mean Best Corrected Visual Acuity change with ranibizumab (0.5 mg) vs Laser
[Time Frame: 4 weeks]
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Monitoring and registry of all adverse events, serious adverse events, visual acuity, concomitant medications, ophthalmologic exams (including count of fingers and movement of the hands), intraocular pressure, vital constants and analytical parameters.
[Time Frame: 4 weeks]
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Time and mean change in central retinal thickness by optical coherence tomography (OCT) with ranibizumab (0.5 mg) vs Laser
[Time Frame: 4 weeks]
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Secondary ID(s)
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CRFB002DES01
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EudraCT 2009-010825-37
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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