Assessment of Patients Treated With JETREA® for Vitreomacular Traction

Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)

The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.

After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).

Inclusion Criteria:

• Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMA visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
• Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
• Hypersensitivity to ocriplasmin or any of the JETREA® excipients.
• Active or suspected intraocular or periocular infection.
• Presence of Epiretinal Membrane (ERM) over the macula at baseline.
• Broad VMT/VMA >1500 microns at baseline.
• History of vitrectomy in the study eye.
• History of laser photocoagulation to the macula in the study eye.
• Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period.
• Macular hole of >400µm diameter in the study eye.
• High myopia in the study eye.
• Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
• Aphakia.
• History of retinal detachment.
• Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.
• Recent ocular surgery or ocular injection.
• Vitreous hemorrhage.
• Exudative age-related macular degeneration (AMD).
• Therapy with another investigational agent within 30 days prior to Visit 1.
• Active, simultaneous enrollment in another ophthalmology clinical study.
• Other protocol-defined exclusion criteria may apply.