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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01492400
First received: December 13, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Macular Edema
 Drug: dexamethasone Intravitreal Implant
Drug: ranibizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Best Corrected Visual Acuity (BCVA) Score [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Total Area of Macular Leakage Measured on Fluorescein Angiography (FA) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]

Enrollment: 363
Study Start Date: March 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
 Drug: dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
Other Name: Ozurdex®
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.
 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.
Other Name: Lucentis®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 or 2 diabetes mellitus
  • Diagnosis of macular edema
  • Visual acuity between 20/200 to 20/40

Exclusion Criteria:

  • Eye surgery to the study eye within 3 months
  • Use of Ozurdex® within 9 months
  • Any active ocular inflammation and infection
  • Diagnosis of glaucoma
  • Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492400

Locations
United States, Texas
Arlington, Texas, United States
Belgium
Brussels, Belgium
Denmark
Glostrup, Denmark
France
Paris, France
Germany
Ahaus, Germany
Israel
Tel Aviv, Israel
Italy
Udine, Italy
Netherlands
Nymegen, Netherlands
Portugal
Coimbra, Portugal
South Africa
Pretoria, South Africa
Spain
Barcelona, Spain
United Kingdom
London, England, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01492400     History of Changes
Other Study ID Numbers: 206207-024
Study First Received: December 13, 2011
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013