Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571232
• Other study ID #: IIT-406
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2021
• Source: Retina Macula Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• dexamethasone intravitreal implant
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
• intravitreal bevacizumab
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Locations

Country	Name	City	State
United States	Retina Macula Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Retina Macula Institute	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Visual Acuity (Number of ETDRS Letters).	The measure the change in ETDRS letters for each treatment group from baseline to 6 months.	6 months
Primary	The Change in Central Foveal Thickness (Microns on High Resolution OCT).	The measure the change in central foveal thickness for each treatment group from baseline to 6 months.	6 months
Secondary	The Change in Macular Leakage on Fluorescein Angiography From Baseline	To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.	6 months
Secondary	The Change in Mean Macular Sensitivity on Microperimetry From Baseline	To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.	6 months
Secondary	The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.	To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.	6 months