Clinical trial NCT02322229: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Official title: Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitreomacular Traction
Vitreomacular Adhesion
Keywords: VMT
sVMA
vitrectomy
ocriplasmin
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 28
Secondary outcomes:
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180
timeFrame: Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
measure: Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)
timeFrame: Day 7, Day 28, Day 90, Day 180
measure: Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180
timeFrame: Baseline (Day 0), Day 7, Day 90, Day 180
measure: Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
timeFrame: Day 180
measure: Change From Baseline in Central Foveal Thickness at Days 28 and 180
timeFrame: Baseline (Day 0), Day 28, Day 180
Other outcomes:
Locations:
city: New South Wales
country: Australia
facility: Contact Alcon Laboratories (Australia) for Trial Locations
Study officials:
affiliation: Alcon, A Novartis Division
name: Associate Dir of Operations, Ophthalmology, GMA
role: STUDY_DIRECTOR
References: