Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

Sponsor
Novartis
Study ID
NCT00989989
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.
  • Laser photocoagulation — PROCEDURE
    Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.
  • Sham ranibizumab — DRUG
    Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.
  • Sham laser photocoagulation — PROCEDURE
    Sham laser treatment administered at day 1.

Study Details

This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).

Key Dates

First listed
Oct 6, 2009
Start date
Sep 30, 2009
Status verified
Sep 2012
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: Adjunctive treatment
    Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
  • Experimental: Monotherapy treatment
    Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
  • Active Comparator: Laser control
    Active laser treatment plus sham intravitreal injections.

Primary Outcome Measure

Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline) [ Time Frame: 12 months ]

Related Studies