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Ocriplasmin Research to Better Inform Treatment (ORBIT) (ORBIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT02079883
First received: March 4, 2014
Last updated: June 20, 2016
Last verified: June 2016
  Purpose
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.

Condition
Symptomatic Vitreomacular Adhesion

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Ocriplasmin Research to Better Inform Treatment (ORBIT)

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician. [ Time Frame: 12 Months ]
  • Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician [ Time Frame: 12 months ]
  • Mean change in visual acuity (VA) from baseline across time [ Time Frame: 12 months ]
  • Occurrence and time to vitrectomy [ Time Frame: 12 months ]

Other Outcome Measures:
  • Monitoring of adverse drug reactions (ADRs) [ Time Frame: 12 months ]
  • Change from baseline in ocular signs and symptoms across time. [ Time Frame: 12 months ]

Biospecimen Retention:   None Retained
No biospecimens collected

Enrollment: 540
Study Start Date: May 2014
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ocriplasmin

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will assess clinical outcomes and safety in patients treated with JETREA® administered in a real-world setting for the treatment of symptomatic VMA
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079883

  Show 110 Study Locations
Sponsors and Collaborators
ThromboGenics
  More Information

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT02079883     History of Changes
Other Study ID Numbers: TG-MV-018
Study First Received: March 4, 2014
Last Updated: June 20, 2016

ClinicalTrials.gov processed this record on August 22, 2017