Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

November 3, 2015 updated by: Raj K. Maturi, MD

A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Study Type

Interventional

Enrollment (Actual)

45

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 PC

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:

  1. Male of female age 18 years or older
  2. Type 1 or Type 2 diabetes
  3. Best corrected visual acuity (BCVA) score of >24 and <78 letters
  4. History of at least 3 anti-VEGF intravitreal injections over the past 5 months
  5. Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT

Exclusion Criteria:

  1. Anti-VEGF intravitreal treatment in the last 4 weeks
  2. Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
  3. Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
  4. Active iris neovascularization
  5. Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
  6. Uncontrolled systemic disease
  7. Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
  8. Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
  9. Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
  10. Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study
  11. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  12. Aphakia or pseudophakia with anterior chamber intraocular lens
  13. Hypersensitivity to any components of Ozurdex or Avastin

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bevacizumab
1.25 mg intravitreal injection given monthly during a 6 month period
Drug: Bevacizumab
antiVEGF
Other Names:
  • Avastin
ACTIVE_COMPARATOR: Ozurdex
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Drug: Ozurdex
intravitreal steroid
Other Names:
  • Dexamethasone Intravitreal Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Visual Acuity Change
Time Frame: baseline to month 7
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
baseline to month 7
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Time Frame: baseline to month seven
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
baseline to month seven

Collaborators and Investigators

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

Sponsor

Raj K. Maturi, MD

Collaborators

Allergan

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

January 1, 2014

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA 003

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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