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

November 29, 2017 updated by: Rhonda Weeks, Retina Research Institute, LLC

Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • The Retina Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Ozurdex implant
Intravitreal injection of Ozurdex implant
Drug: Ozurdex implant
Intravitreal injection of Dexamethasone implant
Other Names:
  • Dexamethasone implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Research Institute, LLC

Collaborators

Retina-Vitreous Associates Medical Group
West Coast Retina Medical Group, Inc.

Investigators

  • Principal Investigator: Gaurav K Shah, MD, Retina Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

September 16, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ozurdex RVO 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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