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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ozurdex
Bevacizumab
Sponsored by
Raj K. Maturi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

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

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

Sites / Locations

  • Raj K Maturi MD PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bevacizumab

Ozurdex

Arm Description

1.25 mg intravitreal injection given monthly during a 6 month period

Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections

Outcomes

Primary Outcome Measures

Mean Visual Acuity Change
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.
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From 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.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2014
Last Updated
November 3, 2015
Sponsor
Raj K. Maturi, MD
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02036424
Brief Title
Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raj K. Maturi, MD
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
1.25 mg intravitreal injection given monthly during a 6 month period
Arm Title
Ozurdex
Arm Type
Active Comparator
Arm Description
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
Dexamethasone Intravitreal Implant
Intervention Description
intravitreal steroid
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
antiVEGF
Primary Outcome Measure Information:
Title
Mean Visual Acuity Change
Description
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.
Time Frame
baseline to month 7
Title
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Description
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.
Time Frame
baseline to month seven

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male of female age 18 years or older Type 1 or Type 2 diabetes Best corrected visual acuity (BCVA) score of >24 and <78 letters History of at least 3 anti-VEGF intravitreal injections over the past 5 months Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT Exclusion Criteria: Anti-VEGF intravitreal treatment in the last 4 weeks Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months Pan retinal photocoagulation (PRP) or focal laser in the last 4 months Active iris neovascularization Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result Uncontrolled systemic disease Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception 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 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. Aphakia or pseudophakia with anterior chamber intraocular lens Hypersensitivity to any components of Ozurdex or Avastin
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 PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States

12. IPD Sharing Statement

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

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