A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients (REFINE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema; Visual Impairment

Treatments: Procedure: Laser; Drug: Ranibizumab (RFB002); Drug: Sham injection; Procedure: Sham laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02259088

CRFB002D2305

Details and patient eligibility

About

Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Full description

The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Enrollment: 384 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
• Stable medication for diabetes within 3 months prior to Visit 1
• Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

Key Exclusion Criteria:

• Stroke or myocardial infarction less than 3 months prior to screening visit
• Uncontrolled hypertension
• Active ocular infection or intraocular inflammation in any eye
• Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
• Active proliferative diabetic retinopathy in study eye
• Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
• Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
• History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 2 patient groups

Ranibizumab (RFB002)

Experimental group

Description:

3 initial intravitreal injections to the study eye at Day 1, Month 1 and Month 2, followed by as-needed intravitreal injections of ranibizumab 0.5 mg guided by VA stabilization, plus sham laser

Treatment:

Drug: Ranibizumab (RFB002)

Procedure: Sham laser

Laser

Active Comparator group

Description:

Laser photocoagulation applied to the study eye at Day 1, followed by active laser photocoagulation at intervals no shorter than 3 months apart, plus sham injections

Treatment:

Procedure: Laser

Drug: Sham injection