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Sponsored by: |
University of Athens |
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Information provided by: | University of Athens |
ClinicalTrials.gov Identifier: | NCT00505947 |
The purpose of this study is to determine if treatment with infliximab improves macular edema which is refractory to laser photocoagulation in patients with diabetes.
Condition | Intervention | Phase |
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Diabetic Macular Edema Visual Acuity Diabetic Retinopathy |
Drug: infliximab Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Infliximab for Diabetic Macular Edema Refractory to Laser Photocoagulation: a Randomized, Double-Masked, Placebo-Controlled, Cross-Over, 32 Weeks Study |
Enrollment: | 12 |
Study Start Date: | July 2007 |
Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Infliximab 5 mg/Kg body weight by intravenous infusion on visit 1 (week 0), visit 2 (week 2), visit 3 (week 6)and visit 5 (week 14). Afterwards, after a washout period of 2 weeks, arm A will receive placebo at visits 6 (week 16), visit 7 (week 18), visit 8 (week 22)and visit 30 (week 30) |
Drug: infliximab
infliximab 5 mg/Kg body weight by intravenous infusion
Drug: placebo
placebo 5 mg/Kg body weight by intravenous infusion
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B: Placebo Comparator
Arm B will receive placebo at visit 1 (week 0), visit 2 (week 2), visit 3 (week 6)and visit 5 (week 14). Afterwards, after a washout period of 2 weeks, group B will receive infliximab 5 mg/Kg body weight by intravenous infusion at visit 6 (week 16), visit 7 (week 18), visit 8 (week 22)and visit 30 (week 30) |
Drug: infliximab
infliximab 5 mg/Kg body weight by intravenous infusion
Drug: placebo
placebo 5 mg/Kg body weight by intravenous infusion
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Stable diabetic therapy within the last 6 months, i.e. absence of major change in glycemic control (e.g.
2% change in HbA1c) or change in daily number of insulin injections.
Exclusion Criteria:
Greece | |
University of Athens | |
Athens, Greece, 11527 | |
Medical School, University of Athens | |
Athens, Greece, 11527 |
Principal Investigator: | Petros Sfikakis, MD | University of Athens |
Responsible Party: | University of Athens ( Petros Sfikakis ) |
Study ID Numbers: | C0168X97, EU-0129 |
Study First Received: | July 23, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00505947 History of Changes |
Health Authority: | Greece: National Organization of Medicines |
macular edema diabetes mellitus visual loss diabetic retinopathy |
macula maculopathy infliximab |
Anti-Inflammatory Agents Infliximab Eye Diseases Diabetes Mellitus Vascular Diseases Retinal Degeneration Edema Endocrine System Diseases Macular Degeneration |
Vision, Low Diabetic Angiopathies Macular Edema Signs and Symptoms Diabetic Retinopathy Endocrinopathy Antirheumatic Agents Retinal Diseases Diabetes Complications |
Anti-Inflammatory Agents Infliximab Eye Diseases Gastrointestinal Agents Vascular Diseases Diabetes Mellitus Retinal Degeneration Edema Endocrine System Diseases Macular Degeneration Pharmacologic Actions |
Diabetic Angiopathies Macular Edema Signs and Symptoms Diabetic Retinopathy Therapeutic Uses Cardiovascular Diseases Antirheumatic Agents Dermatologic Agents Retinal Diseases Diabetes Complications |