Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Retina Macula Institute

Status and phase: Completed; Phase 2

Conditions: Non-proliferative Diabetic Retinopathy; Diabetic Macular Edema; Proliferative Diabetic Retinopathy

Treatments: Drug: intravitreal bevacizumab; Drug: dexamethasone intravitreal implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01571232

IIT-406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Ozurdex

Active Comparator group

Description:

Patients in this group receive Ozurdex at initial visit and at month 4

Treatment:

Drug: dexamethasone intravitreal implant

Avastin

Active Comparator group

Description:

Patients in this group receive Avastin Q1 month for 5 months.

Treatment:

Drug: intravitreal bevacizumab