Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Alcon

Status and phase

Completed

Phase 4

Conditions

Vitreomacular Traction

Vitreomacular Adhesion

Treatments

Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume

Study type

Interventional

Funder types

Industry

Identifiers

NCT02322229

RTA255-P001

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.