Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 474

Inclusion Criteria

- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (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.
- Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 332

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 study eye
- Pseudo-exfoliation, Marfan’s syndrome, phacodonesis or any other finding in the Investigator’s opinion suggesting lens/zonular instability.
- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To observe the anatomical and functional outcomes of ocriplasmin over a 6-month follow-up period;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects with nonsurgical resolution of focal vitreomacular traction (VMT/sVMA), as determined by Central Reading Center (CRC) SD-OCT evaluation;Timepoint(s) of evaluation of this end point: Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Changes in best-corrected visual acuity (BCVA) at distance compared to Baseline <br>2. Proportion of subjects with closure of macular hole (MH) (if present at baseline)<br>3. Proportion of subjects with nonsurgical resolution of VMT/sVMA<br>4. Proportion of subjects experiencing Pars plana vitrectomy (PPV)<br>5. Change in central foveal thickness compared to Baseline;Timepoint(s) of evaluation of this end point: 1. Baseline, Days 28, 90 and 180<br>2. Baseline, Days 28, 90 and 180 <br>3. Days 90 and 180<br>4. Day 180<br>5. Baseline, Days 28 and 180