Assessment of Patients Treated With JETREA® for Vitreomacular Traction (NCT02035748) | Clinical Trial Compass
CompletedPhase 4
Assessment of Patients Treated With JETREA® for Vitreomacular Traction
628 participantsStarted 2014-04
Plain-language summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation