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Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

This study is currently recruiting participants.
Verified January 2013 by Retina Macula Institute
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Ron P. Gallemore, Retina Macula Institute
ClinicalTrials.gov Identifier:
NCT01571232
First received: April 2, 2012
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema.
Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
 Drug: dexamethasone intravitreal implant
Drug: intravitreal bevacizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Retina Macula Institute:

Primary Outcome Measures:
  • The change in visual acuity (number of ETDRS letters). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The measure the change in ETDRS letters for each treatment group from baseline to 6 months.

  • The change in central foveal thickness (microns on high resolution OCT). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The measure the change in central foveal thickness for each treatment group from baseline to 6 months.


Secondary Outcome Measures:
  • The change in macular leakage on fluorescein angiography from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.

  • The change in mean macular sensitivity on microperimetry from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.

  • The change in mean central amplitude on multi-focal ERG from baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ozurdex
Patients in this group receive Ozurdex at initial visit and at month 4
 Drug: dexamethasone intravitreal implant
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
Other Name: Ozurdex
Active Comparator: Avastin
Patients in this group receive Avastin Q1 month for 5 months.
 Drug: intravitreal bevacizumab
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Other Name: Avastin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571232

Contacts
Contact: Gina Kim, B.S 310-944-9393 gina.kim@retinamaculainstitute.com

Locations
United States, California
Retina Macula Institute Recruiting
Torrance, California, United States, 90503
Contact: Gina Kim, B.S     310-944-9393     gina.kim@retinamaculainstitute.com    
Principal Investigator: Ron P Gallemore, M.D, Ph.D            
Sub-Investigator: Mehran Taban, M.D            
Sub-Investigator: Ray Oyakawa, M.D            
Sub-Investigator: Behnam Sharareh, B.S            
Sponsors and Collaborators
Retina Macula Institute
Allergan
Investigators
Principal Investigator: Ron P Gallemore, M.D, Ph.D Retina Macula Institute
Study Director: Behnam Sharareh, B.S Retina Macula Institute
  More Information

No publications provided

Responsible Party: Ron P. Gallemore, Physician and CEO of Retina Macula Institute, Retina Macula Institute
ClinicalTrials.gov Identifier: NCT01571232     History of Changes
Other Study ID Numbers: IIT-406
Study First Received: April 2, 2012
Last Updated: January 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Retina Macula Institute:
Macular Edema
DME
PDR
NPDR
 Ozurdex
Dexamethasone
Avastin
Bevacizumab

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Dexamethasone acetate
 Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 23, 2013