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OpenTrials
Completed

NCT Number: NCT02079883

Ocriplasmin Research to Better Inform Treatment (ORBIT)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Associated Retina Consultants, Ltd, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.

    Time frame: 12 Months

  2. Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician

    Time frame: 12 months

  3. Mean change in visual acuity (VA) from baseline across time

    Time frame: 12 months

  4. Occurrence and time to vitrectomy

    Time frame: 12 months

Other outcomes

  1. Monitoring of adverse drug reactions (ADRs)

    Time frame: 12 months

  2. Change from baseline in ocular signs and symptoms across time.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Acronym: ORBIT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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