CompletedNot Applicable

Ocriplasmin Research to Better Inform Treatment (ORBIT)

United States540 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 12 Months

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

Timeframe: 12 months

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

Timeframe: 12 months

Occurrence and time to vitrectomy

Timeframe: 12 months

Trial details

NCT IDNCT02079883

SponsorThromboGenics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Symptomatic Vitreomacular Adhesion trials