EUCTR2013-005464-25-NL
Active, not recruiting
Not Applicable
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
DrugsJetrea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alcon Research, Ltd.
- Enrollment
- 474
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Ages Eligible for Study: 18 Years and older
- •\- Genders Eligible for Study: Both
- •\- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 142
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 study eye
Outcomes
Primary Outcomes
Not specified
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