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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT. Ozurdex (dexamethasone) 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: Increase of > 50 microns from the best previous CRT measurement Recurrence of intraretinal cystic edema 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).

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone implant up to every 3 Mo.<br>Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time > 3 months following last injection in group 1 if any of the following conditions are met: Increase of > 50 microns from the best previous CRT measurement Recurrence of intraretinal cystic edema Persistent intraretinal cystic edema | Drug: Dexamethasone<br>* Ozurdex (dexamethasone) 0.7mg steroid implant<br>* Other names: DEX PS DDS;|
| Active Comparator: Dexamethasone implant up to every 6 Mo.<br>Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time >6 months following last injection in group 2 if any of the following conditions are met: Increase of > 50 microns from the best previous CRT measurement Recurrence of intraretinal cystic edema Persistent intraretinal cystic edema | Drug: Dexamethasone<br>* Ozurdex (dexamethasone) 0.7mg steroid implant<br>* Other names: DEX PS DDS;|
| Sham Comparator: Sham Implant<br>Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2. Sham implantation may occur at any time > 6 months following last sham injection in group 3 if any of the following conditions are met: Increase of > 50 microns from the best previous CRT measurement Recurrence of intraretinal cystic edema Persistent intraretinal cystic edema | Drug: Dexamethasone<br>* Ozurdex (dexamethasone) 0.7mg steroid implant<br>* Other names: DEX PS DDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity Gain | Measured visual acuity gain in number of letters improved as a result of treatment | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Retinal Thickness Reduction | Central Retinal Thickness Reduction as measured by Heidelberg OCT | 1 year | 
| Comparison of Efficacy Between Group 1 and 2 | Comparison of efficacy between group 1 and group 2 | 3 years | 
| Visual Acuity Gain at Year 2 and 3 | VA gain in ETDRS letters at years 2 and years 3 | 3 years | 
| Time to Reimplantation of Ozurdex Implant | Time in months until new implant is needed | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DME, Diabetic Macular Edema, Pars Plana Vitrectomy