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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. At least 18 years age of at the time of informed consent
2. Diagnosed with VMT/sVMA, with evidence of focal VMT visible on SD-OCT.
3. An Institutional Review Board/Ethics Committee-approved informed consent form must be
read, signed, and dated by the participating subject.

Exclusion Criteria

1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded if:
a. they are currently pregnant,
b. have a positive result on the urine pregnancy test at Screening,
c. intend to become pregnant during the study period,
d. they are breastfeeding, or
e. are not in agreement to use adequate birth control methods to prevent pregnancy
throughout the study.
2. Hypersensitivity to ocriplasmin or any of the JETREA excipients
3. Active or suspected intraocular or periocular infection
4. Presence of Epiretinal Membrane (ERM) over the macula at baseline.
5. Broad VMT/VMA >1500 microns at Baseline.
6. History of vitrectomy in the study eye.
7. History of laser photocoagulation to the macula in the study eye.
8. 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.
9. Macular hole of >400*m diameter in the study eye.
10. High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive
surgery that makes refraction assessment unreliable for myopia severity approximation, in
which case axial length >28mm is an exclusion)
11. Pseudo-exfoliation, Marfan*s syndrome, phacodonesis or any other finding in the
Investigator*s opinion suggesting lens/zonular instability.
12. Therapy with another investigational agent within 30 days prior to Visit 1.
13. Active, simultaneous enrollment in another ophthalmology clinical study.
14. Aphakia.
15. History of Retinal Detachment.
16. Recent ocular surgery or ocular injection within the past 3 months (including laser therapy).
17. Proliferative diabetic retinopathy.
18. Ischaemic retinopathies
19. Retinal vein occlusions.
20. Exudative age-related macular degeneration (AMD).
21. Vitreous hemorrhage.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Proportion of subjects with nonsurgical resolution of focal vitreomacular<br /><br>traction (VMT/sVMA) at Day 28, as determined by Central Reading Center (CRC)<br /><br>SD-OCT evaluation.</p><br>

Secondary Outcome Measures