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Completed

NCT Number: NCT01571232

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.

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Key information

Conditions

Diabetic Macular Edema Eye Diseases Macular Degeneration Macular Edema Non-Proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retina Macula Institute

Torrance, California, 90503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)

Other names: Ozurdex

Intravitreal Bevacizumab

Drug

Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Other names: Avastin

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. The Change in Mean Macular Sensitivity on Microperimetry From Baseline

    Time frame: 6 months

    To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.

  3. 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.

Sponsors and collaborators

Lead sponsor

Retina Macula Institute

Other

Collaborators

  • Allergan

Registry information

Official study title

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 5, 2012
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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