Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

NCT ID: NCT01571232

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ozurdex

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

Group Type: ACTIVE_COMPARATOR

dexamethasone intravitreal implant

Intervention Type: DRUG

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

Avastin

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

Group Type: ACTIVE_COMPARATOR

intravitreal bevacizumab

Intervention Type: DRUG

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

Interventions

dexamethasone intravitreal implant

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

Intervention Type: DRUG

intravitreal bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

Ozurdex; Avastin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Retina Macula Institute

OTHER

Sponsor Role: lead

Responsible Party

Ron P. Gallemore

Physician and CEO of Retina Macula Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ron P Gallemore, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Retina Macula Institute

Locations

Retina Macula Institute

Torrance, California, United States

Countries

United States

Other Identifiers

IIT-406

Identifier Type: -

Identifier Source: org_study_id