Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement (RESOLVE)

Novartis

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Ranibizumab 0.3 mg; Drug: Sham injection; Drug: Ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00284050

CRFB002D2201

Details and patient eligibility

About

This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetic macular edema with center involvement in at least one eye
• Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
• Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion criteria

• Patients with uncontrolled systemic or ocular diseases
• Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
• Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 3 patient groups

Ranibizumab 0.3 mg

Experimental group

Description:

Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Treatment:

Drug: Ranibizumab 0.3 mg

Ranibizumab 0.5 mg

Experimental group

Description:

Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Treatment:

Drug: Ranibizumab 0.5 mg

Sham injection

Sham Comparator group

Description:

Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

Treatment:

Drug: Sham injection