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

NCT01788475 | Terminated Results

• 1 other identifier: 2012-031
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; DME; Pars Plana Vitrectomy

Outcome Measures

Primary Outcomes (1)

• Visual Acuity Gain

  Measured visual acuity gain in number of letters improved as a result of treatment

  13 months

Secondary Outcomes (4)

• Central Retinal Thickness Reduction

  1 year

• Comparison of Efficacy Between Group 1 and 2

  3 years

• Visual Acuity Gain at Year 2 and 3

  3 years

• Time to Reimplantation of Ozurdex Implant

  3 years

Study Arms (3)

Dexamethasone implant up to every 3 Mo.

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Dexamethasone implant up to every 6 Mo.

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Sham Implant

SHAM COMPARATOR

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Ozurdex (dexamethasone) 0.7mg steroid implant

Also known as: Ozurdex, Dexamethasone Posterior segment drug delivery system, DEX PS DDS

Dexamethasone implant up to every 3 Mo.; Dexamethasone implant up to every 6 Mo.; Sham Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults\> 18 years of age with type 1 or 2 diabetes mellitus
• Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is \> 300 microns with intraretinal cystic edema
• BCVA between 20/40 to 20/400
• Patient had vitrectomy surgery.
• Provide a signed informed consent prior to any study procedure

You may not qualify if:

• Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
• Patient with history of steroid response with IOP \>35 mm Hg or requirement to be on \> 2 glaucoma medications following previous steroid injection.
• Previous injection of anti-VEGF or steroid in the study eye within 90 days
• Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
• Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
• Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Medical Center, One Essex Center Drive

Peabody, Massachusetts, 01960, United States

Location

Related 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.

  PMID: 19273785 BACKGROUND

• 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.

  PMID: 21813090 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

The study was terminated early leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Christine Gould PAC, MS
• Organization: Lahey Medical Center

christine.gould@lahey.org

9785384412

Study Officials

• Fina C Barouch, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

• Jeffrey L Marx, MD

  Lahey Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: February 22, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 12, 2014
• Last Updated: March 12, 2020
• Results First Posted: May 8, 2019

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)