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

• ClinicalTrials.gov Identifier: NCT01788475
• Recruitment Status: Terminated
• First Posted: February 11, 2013
• Results First Posted: May 8, 2019
• Last Update Posted: March 12, 2020
• Sponsor: Lahey Clinic
• Information provided by (Responsible Party): Jeffrey L. Marx, MD, Lahey Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema	Drug: Dexamethasone	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema
• Actual Study Start Date: February 22, 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 12, 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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: Increase of > 50 microns from the best previous CRT measurement; Recurrence of intraretinal cystic edema; Persistent intraretinal cystic edema	Drug: Dexamethasone; Ozurdex (dexamethasone) 0.7mg steroid implant; Other Names: Ozurdex; Dexamethasone Posterior segment drug delivery system; DEX PS DDS
Active Comparator: 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: Increase of > 50 microns from the best previous CRT measurement; Recurrence of intraretinal cystic edema; Persistent intraretinal cystic edema	Drug: Dexamethasone; Ozurdex (dexamethasone) 0.7mg steroid implant; Other Names: Ozurdex; Dexamethasone Posterior segment drug delivery system; DEX PS DDS
Sham Comparator: 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: Increase of > 50 microns from the best previous CRT measurement; Recurrence of intraretinal cystic edema; Persistent intraretinal cystic edema	Drug: Dexamethasone; Ozurdex (dexamethasone) 0.7mg steroid implant; Other Names: Ozurdex; Dexamethasone Posterior segment drug delivery system; DEX PS DDS

Outcome Measures

Primary Outcome Measures :

1. Visual Acuity Gain [ Time Frame: 13 months ]
   Measured visual acuity gain in number of letters improved as a result of treatment

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Lahey Medical Center, One Essex Center Drive

Peabody, Massachusetts, United States, 01960

Sponsors and Collaborators

Lahey Clinic

Investigators

• Principal Investigator: Fina C Barouch, MD; Lahey Clinic
• Study Chair: Jeffrey L Marx, MD; Lahey Clinic

More Information

Publications:

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.

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.

• Responsible Party: Jeffrey L. Marx, MD, Principal Investigator, Lahey Clinic
• ClinicalTrials.gov Identifier: NCT01788475
• Other Study ID Numbers: 2012-031
• First Posted: February 11, 2013
• Results First Posted: May 8, 2019
• Last Update Posted: March 12, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jeffrey L. Marx, MD, Lahey Clinic:

Diabetic Macular Edema; DME; Pars Plana Vitrectomy

Additional relevant MeSH terms:

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Dexamethasone; Dexamethasone acetate; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action