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.
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 Type
OBSERVATIONAL
Enrollment
540
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
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Retinal COnsultants of Arizona
Phoenix, Arizona, United States
Associated Retina Consultants, Ltd
Phoenix, Arizona, United States
Retina Vitreous Assciates Medical Group
Beverly Hills, California, United States
Valley Retina Institute, PA
Encino, California, United States
California Eye Institute
Fresno, California, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
South Coast Retina Center
Long Beach, California, United States
University of Southern California Medical Center
Los Angeles, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
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