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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Long Island Vitreoretinal Consultants
Sponsor:
Information provided by (Responsible Party):
Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier:
NCT01231633
First received: October 28, 2010
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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 Intervention
Macular Edema
Central Retinal Vein Occlusion
Drug: Ozurdex
Drug: Avastin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Long Island Vitreoretinal Consultants:

Primary Outcome Measures:
  • The change in visual acuity (number of ETDRS letters), at Month 6 as compared with baseline in each treatment arm [ Time Frame: Baseline - Month 6 ] [ Designated as safety issue: No ]
    The change in visual acuity (number of ETDRS 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 ] [ Designated as safety issue: No ]
    Total Number of addiitonal Avastin injections during study- From baseline to Month 6


Secondary Outcome Measures:
  • Presence of macular edema, as measured by ocular coherence tomography (OCT) and fluorescein angiography [ Time Frame: Baseline - Month 6 ] [ Designated as safety issue: No ]
    Presence of macular edema, as measured by ocular coherence tomography (OCT) and fluorescein angiography


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of central retinal vein occlusion (CRVO)
  • Age 18 years or older
  • ETDRS 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231633

Locations
United States, New Jersey
Retina Vitreous Center Recruiting
Toms River, New Jersey, United States, 08755
Contact: Study Coordinator    732-797-3984      
United States, New York
Long Island Vitreoretinal Consultants Recruiting
Great Neck, New York, United States, 11021
Contact: Marianne Schlameuss, RN    516-466-0390      
Contact    516-466-0390      
Principal Investigator: Vincent A Deramo, MD         
Long Island Vitreoretinal Consultants Recruiting
Hauppauge, New York, United States, 11788
Contact: Marianne Schlameuss, RN    631-234-5666      
Contact    631-234-5666      
Principal Investigator: Vincent A Deramo, MD         
Long Island Vitreoretinal Consultants Recruiting
Riverhead, New York, United States, 11901
Contact: Marianne Schlameuss, RN    631-234-5666      
Sponsors and Collaborators
Long Island Vitreoretinal Consultants
Investigators
Principal Investigator: Vincent A Deramo, M.D Long Island Vitreoretinal Consultants
  More Information

No publications provided

Responsible Party: Vincent. A. Deramo, M.D., Prinicipal Investigator, Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier: NCT01231633     History of Changes
Other Study ID Numbers: IST CRVO 1118147
Study First Received: October 28, 2010
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Long Island Vitreoretinal Consultants:
Macular Edema
Central Retinal Vein Occlusion

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 01, 2014