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

NCT02259088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2019-02-01

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-05
Primary Completion
2017-01-17
Completion
2017-01-17

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259088 on ClinicalTrials.gov