MedTrace Logo

Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

NCT01788475 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-03-12

Study results available
· View outcomes & findings →

Summary

Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.

Conditions

Interventions

DRUG

Dexamethasone

Ozurdex (dexamethasone) 0.7mg steroid implant

Sponsors & Collaborators

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Fina C Barouch, MD · Lahey Clinic

  • Jeffrey L Marx, MD · Lahey Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-22
Primary Completion
2014-11-30
Completion
2014-11-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788475 on ClinicalTrials.gov