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Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier:
NCT01309451
First received: March 3, 2011
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

The investigators hypothesize that a combination treatment with Avastin and Ozudex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.


Condition Intervention Phase
Diabetic Macular Edema
 Drug: Bevacizumab
Drug: dexamethasone intravitreal implant
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single Masked, Randomized Controlled Study to Assess EFficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Maturi, Raj K., M.D., P.C.:

Primary Outcome Measures:
  • BCVA measured using ETDRS methodology at month 12 compared to baseline [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab
    intravitreal, 1.25mg., monthly
    Other Name: Avastin
    Drug: dexamethasone intravitreal implant
    0.7mg, intravitreal every 4 months
    Other Name: Ozurdex
  Eligibility

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

Inclusion Criteria:

  • Male or female age 18 years or older
  • Type 1 or type 2 diabetes
  • BCVA score of >24 and <78 letters
  • Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns

Exclusion Criteria:

  • Anti-VEGF intravitreal treatment in last 4 weeks
  • Intravitreal steroid treatment in the last 8 weeks
  • PRP or Focal laser in last 4 months
  • Active iris neovascularization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309451

Locations
United States, Indiana
Raj K. Maturi, MD
Indianapolis, Indiana, United States, 46290
Sponsors and Collaborators
Maturi, Raj K., M.D., P.C.
Investigators
Principal Investigator: Raj K Maturi, MD Midwest Eye Institute
  More Information

No publications provided

Responsible Party: Raj K. Maturi, MD, PI, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01309451     History of Changes
Other Study ID Numbers: OA002
Study First Received: March 3, 2011
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Maturi, Raj K., M.D., P.C.:
diabetic macular edema
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
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
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013