Phase 2 N=20 Randomized Single-blind Treatment

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Diabetic Macular Edema · Non-proliferative Diabetic Retinopathy · Proliferative Diabetic Retinopathy

Bottom Line

View on ClinicalTrials.gov: NCT01571232 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: The Change in Visual Acuity (Number of ETDRS Letters). — 67.8; 71.9; 69.6; 72.9 ETDRS letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dexamethasone intravitreal implant (Drug); intravitreal bevacizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Retina Macula Institute
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY The Change in Visual Acuity (Number of ETDRS Letters).	67.8; 71.9; 69.6; 72.9	—
PRIMARY The Change in Central Foveal Thickness (Microns on High Resolution OCT).	385.9; 341.5; 305.4; 324.3	—
SECONDARY The Change in Macular Leakage on Fluorescein Angiography From Baseline	—	—
SECONDARY The Change in Mean Macular Sensitivity on Microperimetry From Baseline	5.6; 10.7; 7.4; 10.7	—
SECONDARY The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.	27.8; 34.4; 40.9; 30.3	—

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.

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
= 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01571232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.