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

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ClinicalTrials.gov Identifier: NCT01309451
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Bevacizumab Drug: dexamethasone intravitreal implant Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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.

  2. OCT CST [ Time Frame: change in OCT CST from baseline to twelve months ]
    change in optical coherence tomography central subfield thickness



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 7, 2011    Key Record Dates
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Raj K. Maturi, MD, 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
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action