Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 3, 2011
October 28, 2014
March 2011
April 2013   (final data collection date for primary outcome measure)
  • 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
BCVA measured using ETDRS methodology at month 12 compared to baseline [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01309451 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 Ozurdex 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
  • Active Comparator: Bevacizumab alone
    Intervention: Drug: Bevacizumab
  • Active Comparator: Combined group
    Bevacizumab plus Ozurdex
    Interventions:
    • Drug: Bevacizumab
    • Drug: dexamethasone intravitreal implant
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.
October 2014

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