NCT02079883

Ocriplasmin Research to Better Inform Treatment (ORBIT)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 540 (actual)
• Sponsor: ThromboGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

Detailed description

The sites will prospectively enroll consecutive patients eligible for participation in the study. Informed consent will be obtained prior to any data being collected. This study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. Patients will be enrolled at a routinely scheduled visit, on the day of JETREA® administration after the JETREA® injection. No specific visits, examinations, laboratory tests or procedures are mandated as part of this study. There is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. All available and relevant data will be collected prospectively.

Conditions

• Symptomatic Vitreomacular Adhesion

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-03-06
• Last updated: 2016-06-21

Locations

110 sites across 1 country: United States