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

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:

NCT01309451

First received: March 3, 2011

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2011

Last Updated Date

April 24, 2013

Start Date ^ICMJE

March 2011

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

BCVA measured using ETDRS methodology at month 12 compared to baseline [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01309451 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The investigators hypothesize that a combination treatment with Avastin and Ozudex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetic Macular Edema

Intervention ^ICMJE

Drug: Bevacizumab
intravitreal, 1.25mg., monthly

Other Name: Avastin
Drug: dexamethasone intravitreal implant
0.7mg, intravitreal every 4 months

Other Name: Ozurdex

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2013

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01309451

Other Study ID Numbers ^ICMJE

OA002

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Raj K Maturi, MD

Midwest Eye Institute

Information Provided By

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

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top