Diabetic Macular Edema Treated With Ozurdex (DMEO)

NCT01951066 | Completed Phase 2 Results

• 1 other identifier: DMEO-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent

  Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).

  1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent

Study Arms (2)

Group 1 (dexamethasone implant/anti-VEGF)

EXPERIMENTAL

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

Drug: Dexamethasone Implant; Drug: Anti-VEGF injection

Group 2 (anti-VEGF/dexamethasone implant)

EXPERIMENTAL

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

Drug: Dexamethasone Implant; Drug: Anti-VEGF injection

Interventions

Dexamethasone Implant DRUG

Patients will receive a single injection of a dexmethasone implant

Group 1 (dexamethasone implant/anti-VEGF); Group 2 (anti-VEGF/dexamethasone implant)

Anti-VEGF injection DRUG

Patients will receive PRN injections of an anti-VEGF agent

Group 1 (dexamethasone implant/anti-VEGF); Group 2 (anti-VEGF/dexamethasone implant)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: [Peter A. Campochiaro
• Organization: Wilmer Eye Institute, Johns Hopkins University School of Medicine

pcampo@jhmi.edu

(410) 955-5106

Study Officials

• Peter A Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology and Neuroscience

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 29, 2016
• Results First Posted: August 1, 2016

Record last verified: 2016-08

Locations

US (1)