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Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
dexamethasone intravitreal implant
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 Diabetic Macular Edema focused on measuring diabetic macular edema, DME

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female age 18 years or older
  • Type 1 or type 2 diabetes
  • BCVA score of >24 and <78 letters
  • Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns

Exclusion Criteria:

  • Anti-VEGF intravitreal treatment in last 4 weeks
  • Intravitreal steroid treatment in the last 8 weeks
  • PRP or Focal laser in last 4 months
  • Active iris neovascularization

Sites / Locations

  • Raj K. Maturi, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bevacizumab alone

Combined group

Arm Description

Bevacizumab plus Ozurdex

Outcomes

Primary Outcome Measures

Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
OCT CST
change in optical coherence tomography central subfield thickness

Secondary Outcome Measures

Full Information

First Posted
March 3, 2011
Last Updated
October 28, 2014
Sponsor
Maturi, Raj K., M.D., P.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01309451
Brief Title
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
Official Title
A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (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
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
diabetic macular edema, DME

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab alone
Arm Type
Active Comparator
Arm Title
Combined group
Arm Type
Active Comparator
Arm Description
Bevacizumab plus Ozurdex
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
intravitreal, 1.25mg., monthly
Intervention Type
Drug
Intervention Name(s)
dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex
Intervention Description
0.7mg, intravitreal every 4 months
Primary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Description
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (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
baseline to 12 month
Title
OCT CST
Description
change in optical coherence tomography central subfield thickness
Time Frame
change in OCT CST from baseline to twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age 18 years or older Type 1 or type 2 diabetes BCVA score of >24 and <78 letters Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns Exclusion Criteria: Anti-VEGF intravitreal treatment in last 4 weeks Intravitreal steroid treatment in the last 8 weeks PRP or Focal laser in last 4 months Active iris neovascularization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj K Maturi, MD
Organizational Affiliation
Midwest Eye Institute
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

Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

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