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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Procedure: Laser; Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135914

CRFB002DCA05

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable Type 1 or Type 2 diabetes mellitus
• Visual impairment due to focal or diffuse DME in at least one eye

Exclusion criteria

• Active conditions in the study eye that could prevent the improvement of visual acuity on study treatment
• Active eye infection or inflammation
• History of stroke, renal failure or uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 3 patient groups

Combination Therapy

Experimental group

Description:

Participants received ranibizumab intravitreal injection and laser photocoagulation treatments

Treatment:

Procedure: Laser

Drug: ranibizumab

Ranibizumab Monotherapy

Experimental group

Description:

Participants received ranibizumab intravitreal injection therapy only

Treatment:

Drug: ranibizumab

Laser Monotherapy

Active Comparator group

Description:

Participants received Laser photocoagulation therapy only

Treatment:

Procedure: Laser