- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571232
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
March 8, 2021 updated by: Ron P. Gallemore, Retina Macula Institute
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
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
-
-
California
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Torrance, California, United States, 90503
- Retina Macula Institute
-
-
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:
- Presence of NPDR or PDR as confirmed by fluorescein angiography
- Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
- < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections
- Age 18 years or older
- ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)
- Ability to provide written informed consent
- Capable of complying with study protocol.
Exclusion Criteria:
- Intraocular injection of steroid medication within prior 3 months
- Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
- Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
- Prior vitrectomy surgery
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.
- Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ozurdex
Patients in this group receive Ozurdex at initial visit and at month 4
|
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Other Names:
|
Active Comparator: Avastin
Patients in this group receive Avastin Q1 month for 5 months.
|
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change in Visual Acuity (Number of ETDRS Letters).
Time Frame: 6 months
|
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
|
6 months
|
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Time Frame: 6 months
|
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Change in Macular Leakage on Fluorescein Angiography From Baseline
Time Frame: 6 months
|
To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
|
6 months
|
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Time Frame: 6 months
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To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
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6 months
|
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Time Frame: 6 months
|
To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ron P Gallemore, M.D, Ph.D, Retina Macula Institute
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
April 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
April 2, 2012
First Submitted That Met QC Criteria
April 4, 2012
First Posted (Estimate)
April 5, 2012
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Macular Degeneration
- Retinal Diseases
- Diabetic Retinopathy
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Bevacizumab
Other Study ID Numbers
- IIT-406
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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