Assessment of Patients Treated With JETREA® for Vitreomacular Traction

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research

Criteria

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.