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

• Status: Terminated
• Trial end date: 2014-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahey Clinic
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.