DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Lahey Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Macular Edema; DME; Pars Plana Vitrectomy

Intervention: Dexamethasone (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Lahey Clinic

Official(s) and/or principal investigator(s):
Fina C Barouch, MD, Principal Investigator, Affiliation: Lahey Clinic
Jeffrey L Marx, MD, Study Chair, Affiliation: Lahey Clinic


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 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.

Clinical Details

Official title: A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Visual Acuity Gain

Secondary outcome: Central retinal Thickness Reduction

Detailed description: A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3. Patients will be randomly enrolled into 1 of 3 groups: Group 1: Ozurdex administered up to every 3 months Group 2: Ozurdex administered up to every 6 months Group 3: Sham Ozurdex Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT. Ozurdex or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex may occur at any time > 3 months following last injection in group 1 and > 6 months following last injection in group 2 if any of the following conditions are met: 1. Increase of > 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: 1. Adults> 18 years of age with type 1 or 2 diabetes mellitus 2. Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is > 300 microns with intraretinal cystic edema 3. BCVA between 20/40 to 20/400 4. Patient had vitrectomy surgery. 5. Provide a signed informed consent prior to any study procedure Exclusion Criteria: 1. Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition 2. Patient with history of steroid response with IOP >35 mm Hg or requirement to be on > 2 glaucoma medications following previous steroid injection. 3. Previous injection of anti-VEGF or steroid in the study eye within 90 days 4. Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days. 5. Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula. 6. Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.

Locations and Contacts

Lahey Clinic, Peabody, Massachusetts 01960, United States
Additional Information

Starting date: December 2012
Last updated: March 20, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017