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

NCT00284050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2011-02-24

Study results available
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Summary

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

Conditions

Interventions

DRUG

Ranibizumab 0.3 mg

6 mg/ml ranibizumab solution for intravitreal injection

DRUG

Ranibizumab 0.5 mg

10 mg/ml ranibizumab solution for intravitreal injection

DRUG

Sham injection

Non-treatment control for sham intravitreal injection.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Switzerland

Study Locations

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Entities

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 NCT00284050 on ClinicalTrials.gov