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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085734
First Posted: March 12, 2010
Last Update Posted: April 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: April 24, 2013
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

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
Growth Inhibitors
Antineoplastic Agents