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
  Purpose

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


Condition Intervention Phase
Retinal Vein Occlusions
Drug: Avastin
Drug: Osurdex
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Maturi, Raj K., M.D., P.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
Drug: Avastin
1.25mg intravitreally
Active Comparator: Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Drug: Osurdex
0.7mg intravitreally
Drug: Avastin
1.25mg intravitreally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085734

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 Raj K. Maturi, MD, PC
  More Information

No publications provided

Responsible Party: Raj K. Maturi, MD, President, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01085734     History of Changes
Other Study ID Numbers: OA001
Study First Received: March 10, 2010
Results First Received: April 24, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014