NL-OMON40974
Completed
Phase 4
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for VMT/sVMA
Alcon Laboratories0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Vitreomacular traction
- Sponsor
- Alcon Laboratories
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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