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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
Secondary ID [1] 0 0
RTA255-P001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitreomacular Traction 0 0
Vitreomacular Adhesion 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 28
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 7, Day 28, Day 90, Day 180
Secondary outcome [3] 0 0
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 - As described in Primary Outcome Measure
Timepoint [3] 0 0
Baseline (Day 0), Day 7, Day 90, Day 180
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 180
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline (Day 0), Day 28, Day 180

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Contact Alcon Laboratories (Australia) for Trial Locations - New South Wales
Recruitment postcode(s) [1] 0 0
2113 - New South Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alcon Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin
(JETREA™®) over a 6-month period.
Trial website
https://clinicaltrials.gov/show/NCT02322229
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Associate Dir of Operations, Ophthalmology, GMA
Address 0 0
Alcon, A Novartis Division
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications