Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

NCT01571232 | Completed Phase 2 Results

• 1 other identifier: IIT-406
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Macular Edema; DME; PDR; NPDR; Ozurdex; Dexamethasone; Avastin; Bevacizumab

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• The Change in Macular Leakage on Fluorescein Angiography From Baseline

  6 months

• The Change in Mean Macular Sensitivity on Microperimetry From Baseline

  6 months

• The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.

  6 months

Study Arms (2)

Ozurdex

ACTIVE COMPARATOR

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

Drug: dexamethasone intravitreal implant

Avastin

ACTIVE COMPARATOR

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

Drug: intravitreal bevacizumab

Interventions

dexamethasone intravitreal implant DRUG

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

Also known as: Ozurdex

Ozurdex

intravitreal bevacizumab DRUG

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

Also known as: Avastin

Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Macula Institute: lead
• Allergan: collaborator

Study Sites (1)

Retina Macula Institute

Torrance, California, 90503, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Dexamethasone; Calcium Dobesilate; Bevacizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Ron P. Gallemore M.D., Ph.D.
• Organization: Retina Macula Institute

rongallemoremd@gmail.com

310-944-9393

Study Officials

• Ron P Gallemore, M.D, Ph.D

  Retina Macula Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician and CEO of Retina Macula Institute

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 5, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 30, 2021
• Results First Posted: May 31, 2017

Record last verified: 2021-03

Locations

US (1)