Clinical trial NCT02035748: Assessment of Patients Treated With JETREA® for Vitreomacular Traction
Official title: Assessment of Anatomical and Functional Outcomes in Patients 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: Vitreomacular traction
Symptomatic vitreomacular adhesion
Ocriplasmin
JETREA
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 628
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 follow-up period.

Detailed description: After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMA visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
* Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, 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.
* Presence of Epiretinal Membrane (ERM) over the macula at baseline.
* Broad VMT/VMA \>1500 microns at baseline.
* History of vitrectomy in the study eye.
* History of laser photocoagulation to the macula in the study eye.
* Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period.
* Macular hole of \>400µm diameter in the study eye.
* High myopia in the study eye.
* Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
* Aphakia.
* History of retinal detachment.
* Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.
* Recent ocular surgery or ocular injection.
* Vitreous hemorrhage.
* Exudative age-related macular degeneration (AMD).
* Therapy with another investigational agent within 30 days prior to Visit 1.
* Active, simultaneous enrollment in another ophthalmology clinical study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance
timeFrame: Baseline (Day 0), Day 28, Day 90, Day 180
measure: Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline
timeFrame: Day 28, Day 90, Day 180
measure: Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA
timeFrame: Baseline, Day 90, Day 180
measure: Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180
timeFrame: Day 180
measure: Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)
timeFrame: Baseline (Day 0), Day 28, Day 180
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, a Novartis Company
name: Sr Clinical Manager, Ophtha-GCRA
role: STUDY_DIRECTOR
References: