Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Assessment of Anatomical and Functional Outcomes in Subjects 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 period.

Study Overview

• Status: Completed
• Conditions: Vitreomacular Traction; Vitreomacular Adhesion
• Intervention / Treatment: Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales, Australia, 2113
    • Contact Alcon Laboratories (Australia) for Trial Locations

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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 (IVT) injection	Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume; Other Names: JETREA™®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180	BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (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. One eye (study eye) contributed to the analysis.	Day 7, Day 28, Day 90, Day 180
Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180	As described in Primary Outcome Measure	Baseline (Day 0), Day 7, Day 90, Day 180
Percentage 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. One eye (study eye) contributed to the analysis.	Day 180
Change From Baseline in Central Foveal Thickness at Days 28 and 180	Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 28, Day 180

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Associate Dir of Operations, Ophthalmology, GMA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2015
• Primary Completion (ACTUAL): December 11, 2015
• Study Completion (ACTUAL): May 9, 2016

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (ESTIMATE): December 23, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: vitrectomy; VMT; ocriplasmin; sVMA
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: RTA255-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No