Assessment of Patients Treated With JETREA® for Vitreomacular Traction

Alcon

Status and phase

Completed

Phase 4

Conditions

Vitreomacular Traction

Vitreomacular Adhesion

Treatments

Drug: Ocriplasmin

Study type

Interventional

Funder types

Industry

Identifiers

M-13-056

2013-005464-25 (EudraCT Number)

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 follow-up period.

Full 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).

Enrollment

628 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.