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

May 25, 2010
August 20, 2012
June 2010
July 2011   (final data collection date for primary outcome measure)
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.
Mean change from baseline in BCVA (Best Corrected Visual Acuity) Measure: Visual acuity (ETDRS letters) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01131585 on ClinicalTrials.gov Archive Site
Not Provided
  • Number of patients with improvement or loss of BCVA Measure: ETDRS letters [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Time course of BCVA within the two treatment arms. Measure: ETDRS letters [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evaluation of on central retina thickness and other anatomical changes as well as on patient-reported outcomes (PROs) Measure: QoL Questionnaires [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To evaluate the safety for each treatment arm. Measure: adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Total number of treatments in each treatment arm. Measure: Total number of treatments [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Visual Impairment Due to Diabetic Macular Edema
  • 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.
  • 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.
  • 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.

    Interventions:
    • Procedure: Active laser photocoagulation
    • Drug: Ranibizumab 0.5 mg
  • 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.

    Interventions:
    • Procedure: Active laser photocoagulation
    • Drug: Sham injections
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
128
July 2011
July 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01131585
CRFB002DDE13, 2010-018852-29
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP