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Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

NCT01492400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2019-04-17

Study results available
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Summary

This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).

Conditions

  • Macular Edema

Interventions

DRUG

dexamethasone Intravitreal Implant

Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.

DRUG

ranibizumab

Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-09
Primary Completion
2014-02-13
Completion
2014-02-13

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Portugal
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT01492400 on ClinicalTrials.gov