Assessment of Patients Treated With JETREA® for Vitreomacular Traction

Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)

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

Study Overview

• Status: Completed
• Conditions: Vitreomacular Traction; Vitreomacular Adhesion
• Intervention / Treatment: Drug: Ocriplasmin

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).

• Study Type: Interventional
• Enrollment (Actual): 628
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ocriplasmin; Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection	Drug: Ocriplasmin; 0.5 mg/0.2 mL solution for injection; Other Names: JETREA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. 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. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.	Baseline, Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance	BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), 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. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.	Day 28, Day 90, Day 180
Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA	Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. 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. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.	Baseline, Day 90, Day 180
Proportion 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. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.	Day 180
Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)	Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 28, Day 180

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr Clinical Manager, Ophtha-GCRA, Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 11, 2014
• First Submitted That Met QC Criteria: January 11, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: August 19, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Vitreomacular traction; Symptomatic vitreomacular adhesion; Ocriplasmin; JETREA
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: M-13-056; 2013-005464-25 (EudraCT Number)