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

NCT ID: NCT01788475

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-22
• Study Completion Date: 2014-11-12

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).

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexamethasone implant up to every 3 Mo.

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Ozurdex (dexamethasone) 0.7mg steroid implant

Dexamethasone implant up to every 6 Mo.

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

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Ozurdex (dexamethasone) 0.7mg steroid implant

Sham Implant

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

Group Type: SHAM_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Ozurdex (dexamethasone) 0.7mg steroid implant

Interventions

Dexamethasone

Ozurdex (dexamethasone) 0.7mg steroid implant

Intervention Type: DRUG

Other Intervention Names

Ozurdex; Dexamethasone Posterior segment drug delivery system; DEX PS DDS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L. Marx, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fina C Barouch, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic

Jeffrey L Marx, MD

Role: STUDY_CHAIR

Lahey Clinic

Locations

Lahey Medical Center, One Essex Center Drive

Peabody, Massachusetts, United States

Countries

United States

References

Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.

Reference Type: BACKGROUND

PMID: 19273785 (View on PubMed)

Pearson PA, Comstock TL, Ip M, Callanan D, Morse LS, Ashton P, Levy B, Mann ES, Eliott D. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology. 2011 Aug;118(8):1580-7. doi: 10.1016/j.ophtha.2011.02.048.

Reference Type: BACKGROUND

PMID: 21813090 (View on PubMed)

Other Identifiers

2012-031

Identifier Type: -

Identifier Source: org_study_id