search
Back to results

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

Primary Purpose

Visual Impairment Due to Diabetic Macular Edema

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Active laser photocoagulation
Sham injections
Ranibizumab 0.5 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Impairment Due to Diabetic Macular Edema focused on measuring Diabetic macular edema, DME, Proliferative diabetic retinopathy, PDR, ranibizumab, laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active laser photocoagulation and ranibizumab

Active laser photocoagulation and sham injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2010
Last Updated
August 20, 2012
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01131585
Brief Title
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
Acronym
RELATION
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
European drug approval.
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment Due to Diabetic Macular Edema
Keywords
Diabetic macular edema, DME, Proliferative diabetic retinopathy, PDR, ranibizumab, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active laser photocoagulation and ranibizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Active laser photocoagulation and sham injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active laser photocoagulation
Intervention Description
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Intervention Type
Drug
Intervention Name(s)
Sham injections
Intervention Description
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aschaffenburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
Country
Germany
Facility Name
Novartis Investigative Site
City
Darmstadt
Country
Germany
Facility Name
Novartis Investigative Site
City
Dessau
Country
Germany
Facility Name
Novartis Investigative Site
City
Dortmund
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Eichstaett
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Giessen
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Karlsruhe
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
Country
Germany
Facility Name
Novartis Investigative Site
City
Landshut
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
Country
Germany
Facility Name
Novartis Investigative Site
City
Mühlheim
Country
Germany
Facility Name
Novartis Investigative Site
City
München
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
Country
Germany
Facility Name
Novartis Investigative Site
City
Nuernberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Postdam
Country
Germany
Facility Name
Novartis Investigative Site
City
Recklinghausen
Country
Germany
Facility Name
Novartis Investigative Site
City
Regensburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Rosenheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
Country
Germany
Facility Name
Novartis Investigative Site
City
Würzburg
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.NovartisClinicalTrials.com
Description
Click here for more information about this study:

Learn more about this trial

Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

We'll reach out to this number within 24 hrs