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

March 3, 2011
April 24, 2013
March 2011
April 2013   (final data collection date for primary outcome measure)
BCVA measured using ETDRS methodology at month 12 compared to baseline [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01309451 on ClinicalTrials.gov Archive Site
Not Provided
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Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: Bevacizumab
    intravitreal, 1.25mg., monthly
    Other Name: Avastin
  • Drug: dexamethasone intravitreal implant
    0.7mg, intravitreal every 4 months
    Other Name: Ozurdex
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309451
OA002
No
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
Maturi, Raj K., M.D., P.C.
Not Provided
Principal Investigator: Raj K Maturi, MD Midwest Eye Institute
Maturi, Raj K., M.D., P.C.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP