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

March 13, 2014 updated by: Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Raj K. Maturi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Avastin
1.25mg intravitreally
Drug: Osurdex
0.7mg intravitreally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Injections Needed
Time Frame: baseline to 6 months
number of Avastin and Ozurdex injections needed
baseline to 6 months
Change in Macular Thickness and Macular Volume
Time Frame: 6 months
OCT central subfield thickness measured in microns
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maturi, Raj K., M.D., P.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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