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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01788475
Recruitment Status : Terminated (Study withdrawn by Investigator)
First Posted : February 11, 2013
Results First Posted : May 8, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey L. Marx, MD, Lahey Clinic

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).

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. 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:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. 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:

  1. Increase of > 50 microns from the best previous CRT measurement
  2. Recurrence of intraretinal cystic edema
  3. Persistent intraretinal cystic edema
Drug: Dexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant
Other Names:
  • Ozurdex
  • Dexamethasone Posterior segment drug delivery system
  • DEX PS DDS




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788475


Locations
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United States, Massachusetts
Lahey Medical Center, One Essex Center Drive
Peabody, Massachusetts, United States, 01960
Sponsors and Collaborators
Lahey Clinic
Investigators
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Principal Investigator: Fina C Barouch, MD Lahey Clinic
Study Chair: Jeffrey L Marx, MD Lahey Clinic
Publications:
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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    Key Record Dates
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:
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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