search
Back to results

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

Primary Purpose

Macular Edema, Central Retinal Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ozurdex
Avastin
Sponsored by
Long Island Vitreoretinal Consultants
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular Edema, Central Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Vitreous Center
  • Long Island Vitreoretinal Consultants
  • Long Island Vitreoretinal Consultants
  • Long Island Vitreoretinal Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Outcomes

Primary Outcome Measures

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 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
Total Number of addiitonal Avastin injections during study- From baseline to Month 6

Secondary Outcome Measures

Change in Central Mean Thickness Based on OCT
Change in Central Mean Thickness based on OCT from baseline to Month 6t

Full Information

First Posted
October 28, 2010
Last Updated
March 5, 2018
Sponsor
Long Island Vitreoretinal Consultants
search

1. Study Identification

Unique Protocol Identification Number
NCT01231633
Brief Title
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Long Island Vitreoretinal Consultants

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Central Retinal Vein Occlusion
Keywords
Macular Edema, Central Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
Dexamethasone implant
Intervention Description
Ozurdex, 0.7mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Avastin, bevacizumab
Intervention Description
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
Primary Outcome Measure Information:
Title
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
Description
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
Title
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Description
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Time Frame
Baseline - Month 6
Secondary Outcome Measure Information:
Title
Change in Central Mean Thickness Based on OCT
Description
Change in Central Mean Thickness based on OCT from baseline to Month 6t
Time Frame
Baseline to 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent A Deramo, M.D
Organizational Affiliation
Long Island Vitreoretinal Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Vitreous Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Riverhead
State/Province
New York
ZIP/Postal Code
11901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs