Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

March 5, 2018 updated by: Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants

Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Retina Vitreous Center
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultants
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants
      • Riverhead, New York, United States, 11901
        • Long Island Vitreoretinal Consultants

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of central retinal vein occlusion (CRVO)
  • Age 18 years or older
  • ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
  • OCT Central foveal thickness >250 microns
  • Negative pregnancy test for women of childbearing potential
  • Ability to provide written informed consent
  • Capable of complying with study protocol

Exclusion Criteria:

  • History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication
  • History of steroid-related glaucoma (steroid response)
  • Previous intraocular injection of steroid medication within 90 days
  • Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
  • Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
  • Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
  • Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
  • Dense cataract that precludes clinical examination and retinal imaging of the retina
  • History of allergy to dexamethasone, bevacizumab, betadine
  • Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
  • Unwilling or unable to follow or comply with all study related procedures
  • Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Drug: Ozurdex
Ozurdex, 0.7mg dexamethasone
Other Names:
  • Dexamethasone implant
Drug: Avastin
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
Other Names:
  • Avastin, bevacizumab
Active Comparator: Group 2
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Drug: Avastin
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
Other Names:
  • Avastin, bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
Time Frame: Baseline - Month 6
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Baseline - Month 6
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Time Frame: Baseline - Month 6
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Baseline - Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Central Mean Thickness Based on OCT
Time Frame: Baseline to 6 Months
Change in Central Mean Thickness based on OCT from baseline to Month 6t
Baseline to 6 Months

Collaborators and Investigators

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

Sponsor

Long Island Vitreoretinal Consultants

Investigators

  • Principal Investigator: Vincent A Deramo, M.D, Long Island Vitreoretinal Consultants

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, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IST CRVO 1118147

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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