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

Part of paid clinical trials in Arlington, Texas.

Sponsor
Allergan
Study ID
NCT01492400
Phase
PHASE2
Status
Completed

Conditions

  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dexamethasone Intravitreal Implant — DRUG
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
  • ranibizumab — DRUG
    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.

Study Details

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).

Key Dates

First listed
Dec 15, 2011
Start date
Mar 9, 2012
Status verified
Apr 2019
Primary completion
Feb 13, 2014
Completion
Feb 13, 2014

Study Design

Enrollment
363 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: dexamethasone Intravitreal Implant
    Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
  • Active Comparator: 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.

Primary Outcome Measure

Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 12 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
-ArlingtonTexas--

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