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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01788475
• Other study ID #: 2012-031
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2013
• Est. completion date: November 12, 2014

Study information

• Verified date: March 2020
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 12, 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant

Locations

Country	Name	City	State
United States	Lahey Medical Center, One Essex Center Drive	Peabody	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity Gain	Measured visual acuity gain in number of letters improved as a result of treatment	13 months
Secondary	Central Retinal Thickness Reduction	Central Retinal Thickness Reduction as measured by Heidelberg OCT	1 year
Secondary	Comparison of Efficacy Between Group 1 and 2	Comparison of efficacy between group 1 and group 2	3 years
Secondary	Visual Acuity Gain at Year 2 and 3	VA gain in ETDRS letters at years 2 and years 3	3 years
Secondary	Time to Reimplantation of Ozurdex Implant	Time in months until new implant is needed	3 years