Clinical trial NCT01788475: Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
DME
Pars Plana Vitrectomy
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Visual Acuity Gain
timeFrame: 13 months
Secondary outcomes:
measure: Central Retinal Thickness Reduction
timeFrame: 1 year
measure: Comparison of Efficacy Between Group 1 and 2
timeFrame: 3 years
measure: Visual Acuity Gain at Year 2 and 3
timeFrame: 3 years
measure: Time to Reimplantation of Ozurdex Implant
timeFrame: 3 years
Other outcomes:
Locations:
city: Peabody
country: United States
facility: Lahey Medical Center, One Essex Center Drive
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Fina C Barouch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Clinic
name: Jeffrey L Marx, MD
role: STUDY_CHAIR
References:
citation: 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.
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.