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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: October 28, 2014
Last verified: October 2014
  Purpose
The investigators hypothesize that a combination treatment with Avastin and Ozurdex 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:


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

Primary Outcome Measures:
  • Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline [ Time Frame: baseline to 12 month ] [ Designated as safety issue: No ]
    Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

  • OCT CST [ Time Frame: change in OCT CST from baseline to twelve months ] [ Designated as safety issue: No ]
    change in optical coherence tomography central subfield thickness


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)
Arms Assigned Interventions
Active Comparator: Bevacizumab alone Drug: Bevacizumab
intravitreal, 1.25mg., monthly
Other Name: Avastin
Active Comparator: Combined group
Bevacizumab plus Ozurdex
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: November 5, 2013
Last Updated: October 28, 2014
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
Bevacizumab
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016