Vitreomacular Traction Clinical Trial
Official title:
Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
Verified date | October 2017 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.
Status | Completed |
Enrollment | 62 |
Est. completion date | May 9, 2016 |
Est. primary completion date | December 11, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of 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. - Willing and able to attend all study visits. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, 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 in either eye. - Participation in any interventional clinical trial within 30 days prior to baseline. - Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye. - Broad VMT/VMA > 1500 microns at baseline in the study eye. - History of vitrectomy in the study eye. - History of laser photocoagulation to the macula in the study eye. - Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period. - Macular hole of > 400 microns diameter in the study eye. - High myopia in the study eye. - Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability. - Aphakia in the study eye. - History of retinal detachment in the study eye. - Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy). - Proliferative diabetic retinopathy or ischemic retinopathies in the study eye. - Retinal vein occlusions in the study eye. - Exudative age-related macular degeneration (AMD) in the study eye. - Vitreous hemorrhage in the study eye. - Other protocol-specified exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Contact Alcon Laboratories (Australia) for Trial Locations | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation | Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis. | Day 28 | |
Secondary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 7, Day 28, Day 90, Day 180 | |
Secondary | Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline) | The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. One eye (study eye) contributed to the analysis. | Day 7, Day 28, Day 90, Day 180 | |
Secondary | Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 | As described in Primary Outcome Measure | Baseline (Day 0), Day 7, Day 90, Day 180 | |
Secondary | Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 | Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. One eye (study eye) contributed to the analysis. | Day 180 | |
Secondary | Change From Baseline in Central Foveal Thickness at Days 28 and 180 | Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Day 28, Day 180 |
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