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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079883
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

Study Description
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Brief 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.

Condition or disease
Symptomatic Vitreomacular Adhesion

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 540 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Ocriplasmin Research to Better Inform Treatment (ORBIT)
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin

Groups and Cohorts
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Group/Cohort
ocriplasmin


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures:
  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 ]

Biospecimen Retention:   None Retained
No biospecimens collected

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079883


Locations
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Sponsors and Collaborators
ThromboGenics
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT02079883    
Other Study ID Numbers: TG-MV-018
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes