Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

This study is currently recruiting participants. (see Contacts and Locations)
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

April 2, 2012
January 13, 2013
April 2012
June 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01571232 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetic Macular Edema.
  • Non-proliferative Diabetic Retinopathy
  • Proliferative Diabetic Retinopathy
  • Drug: dexamethasone intravitreal implant
    Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
    Other Name: Ozurdex
  • Drug: intravitreal bevacizumab
    Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
    Other Name: Avastin
  • Active Comparator: Ozurdex
    Patients in this group receive Ozurdex at initial visit and at month 4
    Intervention: Drug: dexamethasone intravitreal implant
  • Active Comparator: Avastin
    Patients in this group receive Avastin Q1 month for 5 months.
    Intervention: Drug: intravitreal bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gina Kim, B.S 310-944-9393 gina.kim@retinamaculainstitute.com
United States
 
NCT01571232
IIT-406
No
Ron P. Gallemore, Retina Macula Institute
Retina Macula Institute
Allergan
Principal Investigator: Ron P Gallemore, M.D, Ph.D Retina Macula Institute
Study Director: Behnam Sharareh, B.S Retina Macula Institute
Retina Macula Institute
January 2013

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