Conditions: Diabetic Macular Edema
Keywords: DME visual impairment diabetes macular edema diabetic macular edema ranibizumab laser photocoagulation retinopathy retina
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 241
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received ranibizumab intravitreal injection and laser photocoagulation treatments arm 2: Participants received ranibizumab intravitreal injection therapy only arm 3: Participants received Laser photocoagulation therapy only

Interventions: intervention 1: ranibizumab intervention 2: Laser
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: