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Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

Primary Purpose

Retinal Vein Occlusion (RVO), Macular Edema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ozurdex implant
Sponsored by
Retina Research Institute, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion (RVO)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion Criteria:

  • Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
  • Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
  • Pregnancy
  • Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
  • Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
  • Advanced glaucoma
  • Aphakic eyes with rupture or missing posterior lens capsule
  • Eyes with anterior chamber intraocular lens and missing posterior lens capsule
  • Patients with known hypersensitivity to components of this product

Sites / Locations

  • The Retina Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ozurdex implant

Arm Description

Intravitreal injection of Ozurdex implant

Outcomes

Primary Outcome Measures

Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy

Secondary Outcome Measures

Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography

Full Information

First Posted
September 16, 2013
Last Updated
November 29, 2017
Sponsor
Retina Research Institute, LLC
Collaborators
Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01946399
Brief Title
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
Official Title
Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
enrollment not met
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Research Institute, LLC
Collaborators
Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.
Detailed Description
To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion (RVO), Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex implant
Arm Type
Other
Arm Description
Intravitreal injection of Ozurdex implant
Intervention Type
Drug
Intervention Name(s)
Ozurdex implant
Other Intervention Name(s)
Dexamethasone implant
Intervention Description
Intravitreal injection of Dexamethasone implant
Primary Outcome Measure Information:
Title
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months. Exclusion Criteria: Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes Interval surgical intervention, such as cataract surgery, that may confound visual outcomes. Pregnancy Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including: Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases) Advanced glaucoma Aphakic eyes with rupture or missing posterior lens capsule Eyes with anterior chamber intraocular lens and missing posterior lens capsule Patients with known hypersensitivity to components of this product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaurav K Shah, MD
Organizational Affiliation
Retina Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States

12. IPD Sharing Statement

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Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

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