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

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:
NCT01085734
First received: March 10, 2010
Last updated: March 13, 2014
Last verified: March 2014

March 10, 2010
March 13, 2014
March 2010
October 2011   (final data collection date for primary outcome measure)
Change From Baseline Visual Acuity at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01085734 on ClinicalTrials.gov Archive Site
  • Number of Injections Needed [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    number of Avastin and Ozurdex injections needed
  • Change in Macular Thickness and Macular Volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    OCT central subfield thickness measured in microns
number of injections needed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Retinal Vein Occlusions
  • Drug: Avastin
    1.25mg intravitreally
  • Drug: Osurdex
    0.7mg intravitreally
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01085734
OA001
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 Raj K. Maturi, MD, PC
Maturi, Raj K., M.D., P.C.
March 2014

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