Clinical trial NCT01571232: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema
Official title: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Non-proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Keywords: Macular Edema
DME
PDR
NPDR
Ozurdex
Dexamethasone
Avastin
Bevacizumab
Lead sponsor: Retina Macula Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2012-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: The Change in Visual Acuity (Number of ETDRS Letters).
timeFrame: 6 months
measure: The Change in Central Foveal Thickness (Microns on High Resolution OCT).
timeFrame: 6 months
Secondary outcomes:
measure: The Change in Macular Leakage on Fluorescein Angiography From Baseline
timeFrame: 6 months
measure: The Change in Mean Macular Sensitivity on Microperimetry From Baseline
timeFrame: 6 months
measure: The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
timeFrame: 6 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Retina Macula Institute
state: California
Study officials:
affiliation: Retina Macula Institute
name: Ron P Gallemore, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: