Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01135914
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 fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.
  • Laser — PROCEDURE
    Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.

Study Details

To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in comparison with the current standard of care (laser photocoagulation monotherapy), in patients with visual impairment due to DME.

Key Dates

First listed
Jun 3, 2010
Start date
Jul 31, 2010
Status verified
Oct 2014
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

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

Arms

  • Experimental: Combination Therapy
    Participants received ranibizumab intravitreal injection and laser photocoagulation treatments
  • Experimental: Ranibizumab Monotherapy
    Participants received ranibizumab intravitreal injection therapy only
  • Active Comparator: Laser Monotherapy
    Participants received Laser photocoagulation therapy only

Primary Outcome Measure

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

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