CompletedNot Applicable

A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA

United States134 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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:

What they're measuring

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.

Timeframe: Day 21

Trial details

NCT IDNCT02193945

SponsorThromboGenics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-05

View on ClinicalTrials.gov More Symptomatic Vitreomacular Adhesion (VMA) trials