Ocriplasmin Research to Better Inform Treatment (ORBIT)

ThromboGenics

Status: Completed

Conditions: Symptomatic Vitreomacular Adhesion

Study type: Observational

Funder types: Industry

Identifiers

NCT02079883

TG-MV-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label.
• Willing and able to provide written informed consent

Exclusion criteria

• Patients who are treated with JETREA® for medical conditions outside of the US product label.
• Concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions

Trial design

540 participants in 1 patient group

ocriplasmin