Diabetic Macular Edema Treated With Ozurdex (DMEO)

NCT ID: NCT01951066

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-12-31

Brief Summary

To measure various pro-permeability factors in the aqueous humor of patients with persistent/recurrent diabetic macular edema

Detailed Description

Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone implant over specific VEGF antagonists is that steroids suppress production of multiple pro-permeability factors.

Our primary objective is to measure the pro-permeability factors in the aqueous humor of patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a dexamethasone implant.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Group 1 (dexamethasone implant/anti-VEGF)

Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.

Group Type: EXPERIMENTAL

Dexamethasone Implant

Intervention Type: DRUG

Patients will receive a single injection of a dexmethasone implant

Anti-VEGF injection

Intervention Type: DRUG

Patients will receive PRN injections of an anti-VEGF agent

Group 2 (anti-VEGF/dexamethasone implant)

Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.

Group Type: EXPERIMENTAL

Dexamethasone Implant

Intervention Type: DRUG

Patients will receive a single injection of a dexmethasone implant

Anti-VEGF injection

Intervention Type: DRUG

Patients will receive PRN injections of an anti-VEGF agent

Interventions

Dexamethasone Implant

Patients will receive a single injection of a dexmethasone implant

Intervention Type: DRUG

Anti-VEGF injection

Patients will receive PRN injections of an anti-VEGF agent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Signed informed consent and authorization of use and disclosure of protected health information

• Age more than or equal to 18 years
• Diagnosis of diabetic macular edema
• Intraretinal or subretinal fluid in the macula determined by Spectralis OCT
• Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)
• In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision
• Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

Exclusion Criteria

• • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye

• Intraocular surgery in the study eye within 3 months of study entry
• Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
• Previous use of an anti-VEGF drug within 1 month of study entry
• Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry
• Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
• Inability to comply with study or follow up procedures
• History of glaucoma. (Patients who have undergone filtration surgery may be included)
• Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
• Aphakic eyes with rupture of the posterior lens capsule.
• Eyes with ACIOL and rupture of the posterior lens capsule.
• Patients with hypersensitivity to dexamethasone or to any other components of the product

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Peter A Campochiaro, MD

Professor of Ophthalmology and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A Campochiaro, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

DMEO-001

Identifier Type: -

Identifier Source: org_study_id