Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

• Status: Completed
• Trial end date: 2016-05-09
• 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 period.

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

Details

• Lead Sponsor: Alcon Research

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.