Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery
- Registration Number
- NCT01788475
- Lead Sponsor
- Lahey Clinic
- Brief 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.
- 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: 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:
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone implant up to every 3 Mo. Dexamethasone 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: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone implant up to every 6 Mo. Dexamethasone 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: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Sham Implant Dexamethasone 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: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema
- Primary Outcome Measures
Name Time Method Visual Acuity Gain 13 months Measured visual acuity gain in number of letters improved as a result of treatment
- Secondary Outcome Measures
Name Time Method Central Retinal Thickness Reduction 1 year Central Retinal Thickness Reduction as measured by Heidelberg OCT
Comparison of Efficacy Between Group 1 and 2 3 years Comparison of efficacy between group 1 and group 2
Time to Reimplantation of Ozurdex Implant 3 years Time in months until new implant is needed
Visual Acuity Gain at Year 2 and 3 3 years VA gain in ETDRS letters at years 2 and years 3
Trial Locations
- Locations (1)
Lahey Medical Center, One Essex Center Drive
🇺🇸Peabody, Massachusetts, United States