Symptomatic Vitreomacular Adhesion
Conditions
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.
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.
Interventions
None listed
Sponsors
ThromboGenics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician. | 12 Months |
| Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician | 12 months |
| Mean change in visual acuity (VA) from baseline across time | 12 months |
| Occurrence and time to vitrectomy | 12 months |
Other
| Measure | Time frame |
|---|---|
| Monitoring of adverse drug reactions (ADRs) | 12 months |
| Change from baseline in ocular signs and symptoms across time. | 12 months |
Countries
United States
Outcome results
None listed