NCT02259088

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

A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Macular Edema
• Visual Impairment

Interventions

Type	Name	Description
DRUG	Ranibizumab (RFB002)	Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
PROCEDURE	Laser	Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
DRUG	Sham injection	Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
PROCEDURE	Sham laser	Imitation of an active laser

Timeline

• Start date: 2014-11-05
• Primary completion: 2017-01-17
• Completion: 2017-01-17
• First posted: 2014-10-08
• Last updated: 2019-02-01
• Results posted: 2019-02-01

Locations

28 sites across 1 country: China