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Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT01085734
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

Tracking Information
First Submitted Date  ICMJE March 10, 2010
First Posted Date  ICMJE March 12, 2010
Results First Submitted Date  ICMJE April 24, 2013
Results First Posted Date  ICMJE April 21, 2014
Last Update Posted Date April 21, 2014
Study Start Date  ICMJE March 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Change From Baseline Visual Acuity at 6 Months [ Time Frame: 6 months ]
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
visual acuity [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Number of Injections Needed [ Time Frame: baseline to 6 months ]
    number of Avastin and Ozurdex injections needed
  • Change in Macular Thickness and Macular Volume [ Time Frame: 6 months ]
    OCT central subfield thickness measured in microns
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
Number of Injections Needed [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Official Title  ICMJE A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Brief Summary Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Retinal Vein Occlusions
Intervention  ICMJE
  • Drug: Avastin
    1.25mg intravitreally
  • Drug: Osurdex
    0.7mg intravitreally
Study Arms  ICMJE
  • Active Comparator: Group 1
    Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
    Intervention: Drug: Avastin
  • Active Comparator: Group 2
    Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
    Interventions:
    • Drug: Osurdex
    • Drug: Avastin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2010)
40
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female age 18 years or older
  • Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
  • Best correct visual acuity of greater than 24 and less than 80
  • Presence of macular edema defined as OCT central subfield thickness of >250

Exclusion Criteria:

  • intravitreal anti-VEGF treatment in study eye within six weeks of baseline
  • intravitreal steroid treatment in the study eye within eight weeks of baseline visit
  • PRP in the study eye within 4 month of baseline visit
  • Active iris neovascularization in study eye
  • Uncontrolled systemic disease
  • Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085734
Other Study ID Numbers  ICMJE OA001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
Study Sponsor  ICMJE Maturi, Raj K., M.D., P.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raj K Maturi, MD Raj K. Maturi, MD, PC
PRS Account Maturi, Raj K., M.D., P.C.
Verification Date March 2014

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