Status:
COMPLETED
A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA
Lead Sponsor:
ThromboGenics
Conditions:
Symptomatic Vitreomacular Adhesion (VMA)
Eligibility:
All Genders
18+ years
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 (...
Detailed Description
This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of this study are to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT02193945
Start Date
August 1 2014
End Date
May 1 2015
Last Update
July 9 2015
Active Locations (24)
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1
Retinal Diagnostic Center
Campbell, California, United States, 95008
2
Scripps Clinic
La Jolla, California, United States, 92037
3
Orange County Retina Medical Group
Santa Ana, California, United States, 92705
4
California Retina Consultants
Santa Barbara, California, United States, 93103