Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-26

Study Completion Date

2016-05-09

Brief Summary

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

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Detailed Description

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Conditions

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Vitreomacular Traction Vitreomacular Adhesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ocriplasmin

Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection

Group Type EXPERIMENTAL

Ocriplasmin 0.125 mg in a 0.1 mL volume

Intervention Type DRUG

Interventions

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Ocriplasmin 0.125 mg in a 0.1 mL volume

Intervention Type DRUG

Other Intervention Names

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JETREA™®

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No