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

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Macular Edema Central Retinal Vein Occlusion Drug: Ozurdex Drug: Avastin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
Study Start Date : September 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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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 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
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 Name: Avastin, bevacizumab


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT01231633


Locations
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United States, New Jersey
Retina Vitreous Center
Toms River, New Jersey, United States, 08755
United States, New York
Long Island Vitreoretinal Consultants
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
Sponsors and Collaborators
Long Island Vitreoretinal Consultants
Investigators
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Principal Investigator: Vincent A Deramo, M.D Long Island Vitreoretinal Consultants
More Information
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Responsible Party: Vincent. A. Deramo, M.D., Prinicipal Investigator, Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier: NCT01231633    
Other Study ID Numbers: IST CRVO 1118147
First Posted: November 1, 2010    Key Record Dates
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018
Last Verified: March 2018
Keywords provided by Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants:
Macular Edema
Central Retinal Vein Occlusion
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Bevacizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal