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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, DME, Pars Plana Vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Lahey Medical Center, One Essex Center Drive

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Dexamethasone implant up to every 3 Mo.

Dexamethasone implant up to every 6 Mo.

Sham Implant

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Visual Acuity Gain

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

Secondary Outcome Measures

Central Retinal Thickness Reduction

Central Retinal Thickness Reduction as measured by Heidelberg OCT

Comparison of Efficacy Between Group 1 and 2

Comparison of efficacy between group 1 and group 2

Visual Acuity Gain at Year 2 and 3

VA gain in ETDRS letters at years 2 and years 3

Time to Reimplantation of Ozurdex Implant

Time in months until new implant is needed

Full Information

NCT ID

NCT01788475

First Posted

February 7, 2013

Last Updated

March 3, 2020

Sponsor

Lahey Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01788475

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

Study withdrawn by Investigator

Study Start Date

February 22, 2013 (Actual)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 12, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lahey Clinic

4. Oversight

Data Monitoring Committee

No

5. 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.

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: Increase of > 50 microns from the best previous CRT measurement Recurrence of intraretinal cystic edema 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, DME, Pars Plana Vitrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone implant up to every 3 Mo.

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dexamethasone implant up to every 6 Mo.

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham Implant

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

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

Intervention Description

Ozurdex (dexamethasone) 0.7mg steroid implant

Primary Outcome Measure Information:

Title

Visual Acuity Gain

Description

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

Time Frame

13 months

Secondary Outcome Measure Information:

Title

Central Retinal Thickness Reduction

Description

Central Retinal Thickness Reduction as measured by Heidelberg OCT

Time Frame

1 year

Title

Comparison of Efficacy Between Group 1 and 2

Description

Comparison of efficacy between group 1 and group 2

Time Frame

3 years

Title

Visual Acuity Gain at Year 2 and 3

Description

VA gain in ETDRS letters at years 2 and years 3

Time Frame

3 years

Title

Time to Reimplantation of Ozurdex Implant

Description

Time in months until new implant is needed

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fina C Barouch, MD

Organizational Affiliation

Lahey Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey L Marx, MD

Organizational Affiliation

Lahey Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Lahey Medical Center, One Essex Center Drive

City

Peabody

State/Province

Massachusetts

ZIP/Postal Code

01960

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

19273785

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.

Results Reference

background

PubMed Identifier

21813090

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.

Results Reference

background

Diabetic Macular Edema

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial