Phase 4 N=52 Treatment

Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Vitreomacular Traction · Vitreomacular Adhesion

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View on ClinicalTrials.gov: NCT02322229 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Jul 2018

Primary outcome: Primary: 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 — 26.9 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ocriplasmin 0.125 mg in a 0.1 mL volume (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	26.9	—
SECONDARY Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180	70.6; -1.8; 1.0; 2.1; 3.3	—
SECONDARY Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)	25.0; 50.0; 50.0; 50.0	—
SECONDARY Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180	19.2; 38.5; 40.4	—
SECONDARY Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180	7.7	—
SECONDARY Change From Baseline in Central Foveal Thickness at Days 28 and 180	302.3; -35.5; -17.6	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02322229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.