Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01131585
Phase
PHASE3
Status
Terminated

Conditions

  • Visual Impairment Due to Diabetic Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active laser photocoagulation — PROCEDURE
    Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
  • Sham injections — DRUG
    Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
  • Ranibizumab 0.5 mg — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 27, 2010
Start date
Jun 30, 2010
Status verified
Aug 2012
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 [ Time Frame: 12 months ]