Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01231633
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE November 1, 2010
Results First Submitted Date  ICMJE August 22, 2017
Results First Posted Date  ICMJE April 3, 2018
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
  • The change in visual acuity (number of ETDRS letters), at Month 6 as compared with baseline in each treatment arm [ Time Frame: Month 6 ]
  • The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm [ Time Frame: Month 6 ]
Change History Complete list of historical versions of study NCT01231633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
Presence of macular edema, as measured by ocular coherence tomography (OCT) and fluorescein angiography [ Time Frame: Month 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Official Title  ICMJE Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Central Retinal Vein Occlusion
Intervention  ICMJE
  • Drug: Ozurdex
    Ozurdex, 0.7mg dexamethasone
    Other Name: Dexamethasone implant
  • Drug: Avastin
    Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
    Other Name: Avastin, bevacizumab
Study Arms  ICMJE
  • Experimental: Group 1
    Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
    Interventions:
    • Drug: Ozurdex
    • Drug: Avastin
  • Active Comparator: Group 2
    Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
    Intervention: Drug: Avastin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2010)
30
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231633
Other Study ID Numbers  ICMJE IST CRVO 1118147
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants
Study Sponsor  ICMJE Long Island Vitreoretinal Consultants
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent A Deramo, M.D Long Island Vitreoretinal Consultants
PRS Account Long Island Vitreoretinal Consultants
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP