Assessment of Patients Treated With JETREA® for Vitreomacular Traction

NCT ID: NCT02035748

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 628 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

Brief Summary

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

Detailed 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).

Conditions

Vitreomacular Traction; Vitreomacular Adhesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ocriplasmin

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

Group Type: EXPERIMENTAL

Ocriplasmin

Intervention Type: DRUG

0.5 mg/0.2 mL solution for injection

Interventions

Ocriplasmin

0.5 mg/0.2 mL solution for injection

Intervention Type: DRUG

Other Intervention Names

JETREA®

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr Clinical Manager, Ophtha-GCRA

Role: STUDY_DIRECTOR

Alcon, a Novartis Company

Other Identifiers

2013-005464-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M-13-056

Identifier Type: -

Identifier Source: org_study_id