Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RELATION)

This study has been terminated.
(European drug approval.)
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 July 31, 2014