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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Experimental: Ocriplasmin - Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
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
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
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)
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
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
Timepoint [4] 0 0
Day 180
Secondary outcome [5] 0 0
Change From Baseline in Central Foveal Thickness at Days 28 and 180
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
Sex
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
Not applicable
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
26/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2016
Sample size
Target
Accrual to date
Final
62
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02322229