A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA
OZONE
OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
1 other identifier
observational
134
1 country
24
Brief Summary
The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2014
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 9, 2015
July 1, 2015
9 months
July 11, 2014
July 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.
Day 21
Secondary Outcomes (18)
Proportion of patients with ellipsoid zone disruption, not present at baseline
Up to 6 months
Proportion of patients with ellipsoid zone disruption with resolution
Up to 6 months
Time to onset of ellipsoid zone disruption
Up to 6 months
Time to resolution of ellipsoid zone disruption
Up to 6 months
Proportion of patients that developed subretinal fluid, not present at baseline
Up to 6 months
- +13 more secondary outcomes
Eligibility Criteria
Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)
You may qualify if:
- Must be at least 18 years of age or older.
- Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013 and December 31, 2013 with at least six months of follow up visits post injection. Note: If a patient's second eye was treated, only the first eye treated is eligible for study participation.
- Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.
- Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA® injection with at least one scan between Days 1-21 and the second scan within six months,, including a corresponding visual acuity (VA).
- Be willing and able to provide informed consent.
You may not qualify if:
- Patients treated with JETREA® for medical conditions outside of the product label.
- Patients with other retinal conditions that affect the vitreo-retinal interface, or can lead to retinal atrophy, including but not limited to:
- Neovascular age-related macular degeneration;
- Fibrovascular scar;
- Diabetic macular edema; and
- Proliferative diabetic retinopathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (24)
Retinal Diagnostic Center
Campbell, California, 95008, United States
Scripps Clinic
La Jolla, California, 92037, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
Rush university medical center-Dept ophthalmology
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Sabates Eye Centers
Leawood, Kansas, 66211, United States
Carl W. Baker
Paducah, Kentucky, 42001, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801, United States
MaculaCare
New York, New York, 10021, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates, P.C.
Kingsport, Tennessee, 37660, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Valley Retina Institute, PA
McAllen, Texas, 78503, United States
Retina Specialists
Plano, Texas, 75075, United States
Retina Associates of Utah, P.C.
Salt Lake City, Utah, 84107, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 18, 2014
Study Start
August 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 9, 2015
Record last verified: 2015-07