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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02322229
Registration number
NCT02322229
Ethics application status
Date submitted
17/12/2014
Date registered
23/12/2014
Date last updated
21/08/2018
Titles & IDs
Public title
Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
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Scientific title
Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
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Secondary ID [1]
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RTA255-P001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vitreomacular Traction
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Vitreomacular Adhesion
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ocriplasmin 0.125 mg in a 0.1 mL volume
Experimental: Ocriplasmin - Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
Treatment: Drugs: Ocriplasmin 0.125 mg in a 0.1 mL volume
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Day 28
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Secondary outcome [1]
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Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
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Secondary outcome [2]
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Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)
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Assessment method [2]
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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.
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Timepoint [2]
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Day 7, Day 28, Day 90, Day 180
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Secondary outcome [3]
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Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
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Assessment method [3]
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As described in Primary Outcome Measure
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Timepoint [3]
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Baseline (Day 0), Day 7, Day 90, Day 180
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Secondary outcome [4]
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Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
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Assessment method [4]
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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.
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Timepoint [4]
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Day 180
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Secondary outcome [5]
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Change From Baseline in Central Foveal Thickness at Days 28 and 180
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 0), Day 28, Day 180
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/05/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/05/2016
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Sample size
Target
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Contact Alcon Laboratories (Australia) for Trial Locations - New South Wales
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Recruitment postcode(s) [1]
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2113 - New South Wales
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin
(JETREA™®) over a 6-month period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02322229
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Associate Dir of Operations, Ophthalmology, GMA
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Address
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Alcon, A Novartis Division
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02322229
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