Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RELATION)

Novartis

Status and phase: Terminated; Phase 3

Conditions: Visual Impairment Due to Diabetic Macular Edema

Treatments: Drug: Sham injections; Drug: Ranibizumab 0.5 mg; Procedure: Active laser photocoagulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131585

CRFB002DDE13

2010-018852-29 (EudraCT Number)

Details and patient eligibility

About

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual acuity impairment caused by macular edema in at least one eye
• Type 1 or type 2 diabetes mellitus
• Stable medication of diabetes in past 3 month

Exclusion criteria

• Patients with uncontrolled systemic or ocular diseases
• Laser photocoagulation in the study eye for the last 3 months
• Any history of any intraocular surgery in the study eye within the past 3 months
• Blood pressure > 160/100 mmHg

Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Active laser photocoagulation and ranibizumab

Experimental group

Description:

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Treatment:

Drug: Ranibizumab 0.5 mg

Procedure: Active laser photocoagulation

Active laser photocoagulation and sham injection

Active Comparator group

Description:

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Treatment:

Drug: Sham injections

Procedure: Active laser photocoagulation