Vitreomacular Traction Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 628 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 28 | No | |
Secondary | Change from baseline in best-corrected visual acuity (BCVA) at distance | Baseline (Day 0), up to Day 180 | No | |
Secondary | Proportion of subjects with closure of macular hole (MH), if present at baseline | Up to Day 180 | No | |
Secondary | Proportion of subjects with nonsurgical resolution of VMT/sVMA | Up to Day 180 | No | |
Secondary | Proportion of subjects experiencing pars plana vitrectomy (PPV) at Day 180 | Day 180 | No | |
Secondary | Change from baseline in central foveal thickness | Up to Day 180 | No |
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