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

Lahey Health

Status: Terminated

Conditions: Diabetic Macular Edema

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01788475

2012-031

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 3 patient groups

Dexamethasone implant up to every 3 Mo.

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Dexamethasone implant up to every 6 Mo.

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone

Sham Implant

Sham Comparator group

Description:

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

Treatment:

Drug: Dexamethasone