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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

Primary Purpose

Retinal Vein Occlusions

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Avastin
Osurdex
Avastin
Sponsored by
Maturi, Raj K., M.D., P.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Raj K. Maturi, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema

Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema

Outcomes

Primary Outcome Measures

Change From Baseline Visual Acuity at 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
number of Avastin and Ozurdex injections needed
Change in Macular Thickness and Macular Volume
OCT central subfield thickness measured in microns

Full Information

First Posted
March 10, 2010
Last Updated
March 13, 2014
Sponsor
Maturi, Raj K., M.D., P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01085734
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maturi, Raj K., M.D., P.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
1.25mg intravitreally
Intervention Type
Drug
Intervention Name(s)
Osurdex
Intervention Description
0.7mg intravitreally
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
1.25mg intravitreally
Primary Outcome Measure Information:
Title
Change From Baseline Visual Acuity at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Injections Needed
Description
number of Avastin and Ozurdex injections needed
Time Frame
baseline to 6 months
Title
Change in Macular Thickness and Macular Volume
Description
OCT central subfield thickness measured in microns
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj K Maturi, MD
Organizational Affiliation
Raj K. Maturi, MD, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raj K. Maturi, MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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