Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery
| Status: | Withdrawn |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | November 2014 |
A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema
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.
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.
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).
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).
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.
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