Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RELATION)
This study has been terminated.
(European drug approval.)
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01131585
First received: May 25, 2010
Last updated: August 20, 2012
Last verified: August 2012
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Purpose
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
| Condition | Intervention | Phase |
|---|---|---|
|
Visual Impairment Due to Diabetic Macular Edema |
Procedure: Active laser photocoagulation Drug: Sham injections Drug: Ranibizumab 0.5 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A 12-month, Two-armed, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Laser Photocoagulation as Adjunctive to Ranibizumab Intravitreal Injections vs. Laser Photocoagulation Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema Followed by a 12 Month Follow up Period |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Ranibizumab
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
| Enrollment: | 128 |
| Study Start Date: | June 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active laser photocoagulation and ranibizumab
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
Procedure: Active laser photocoagulation
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Drug: Ranibizumab 0.5 mg
Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
|
|
Active Comparator: Active laser photocoagulation and sham injection
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment. |
Procedure: Active laser photocoagulation
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Drug: Sham injections
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Visual acuity impairment caused by macular edema in at least one eye
- Type 1 or type 2 diabetes mellitus
- Stable medication of diabetes in past 3 month
Exclusion Criteria:
- Patients with uncontrolled systemic or ocular diseases
- Laser photocoagulation in the study eye for the last 3 months
- Any history of any intraocular surgery in the study eye within the past 3 months
- Blood pressure > 160/100 mmHg
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131585
Locations
| Germany | |
| Novartis Investigative Site | |
| Aschaffenburg, Germany | |
| Novartis Investigative Site | |
| Berlin, Germany | |
| Novartis Investigative Site | |
| Bonn, Germany | |
| Novartis Investigative Site | |
| Bremen, Germany | |
| Novartis Investigative Site | |
| Chemnitz, Germany | |
| Novartis Investigative Site | |
| Darmstadt, Germany | |
| Novartis Investigative Site | |
| Dessau, Germany | |
| Novartis Investigative Site | |
| Dortmund, Germany | |
| Novartis Investigative Site | |
| Dresden, Germany | |
| Novartis Investigative Site | |
| Eichstaett, Germany | |
| Novartis Investigative Site | |
| Essen, Germany | |
| Novartis Investigative Site | |
| Frankfurt, Germany | |
| Novartis Investigative Site | |
| Freiburg, Germany | |
| Novartis Investigative Site | |
| Giessen, Germany | |
| Novartis Investigative Site | |
| Hamburg, Germany | |
| Novartis Investigative Site | |
| Heidelberg, Germany | |
| Novartis Investigative Site | |
| Karlsruhe, Germany | |
| Novartis Investigative Site | |
| Kiel, Germany | |
| Novartis Investigative Site | |
| Koeln, Germany | |
| Novartis Investigative Site | |
| Landshut, Germany | |
| Novartis Investigative Site | |
| Leipzig, Germany | |
| Novartis Investigative Site | |
| Marburg, Germany | |
| Novartis Investigative Site | |
| Muenchen, Germany | |
| Novartis Investigative Site | |
| Muenster, Germany | |
| Novartis Investigative Site | |
| Mühlheim, Germany | |
| Novartis Investigative Site | |
| München, Germany | |
| Novartis Investigative Site | |
| Münster, Germany | |
| Novartis Investigative Site | |
| Nuernberg, Germany | |
| Novartis Investigative Site | |
| Postdam, Germany | |
| Novartis Investigative Site | |
| Recklinghausen, Germany | |
| Novartis Investigative Site | |
| Regensburg, Germany | |
| Novartis Investigative Site | |
| Rosenheim, Germany | |
| Novartis Investigative Site | |
| Siegburg, Germany | |
| Novartis Investigative Site | |
| Stuttgart, Germany | |
| Novartis Investigative Site | |
| Ulm, Germany | |
| Novartis Investigative Site | |
| Würzburg, Germany | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01131585 History of Changes |
| Other Study ID Numbers: | CRFB002DDE13, 2010-018852-29 |
| Study First Received: | May 25, 2010 |
| Results First Received: | July 12, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Novartis:
|
Diabetic macular edema DME Proliferative diabetic retinopathy |
PDR ranibizumab laser |
Additional relevant MeSH terms:
|
Edema Macular Edema Vision, Low Vision Disorders Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013