Assessment of Patients Treated With JETREA® for Vitreomacular Traction

Vitreomacular Traction Clinical Trial

Official title:

Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035748
• Other study ID #: M-13-056
• Secondary ID: 2013-005464-25
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2014
• Last updated: September 9, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyBelgium: Ethics CommitteeCanada: Ethics Review CommitteeFrance: Committee for the Protection of PersonnesGermany: Ethics CommissionHungary: Institutional Ethics CommitteeItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteePoland: Ethics CommitteePortugal: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

Subjects will be recruited from approximately 90 centers in approximately 11 countries across Europe and Canada. After receiving a single intravitreal injection as per country's product label (Day 0), subjects will be followed for a 6-month period (Day 180).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (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.

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tissue Adhesions
• Vitreomacular Adhesion
• Vitreomacular Traction

Intervention

Drug:
• Ocriplasmin 0.125 mg in a 0.1 mL volume

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with nonsurgical resolution of focal vitreomacular traction (VMT/VMA) at Day 28, as determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation		Day 28	No
Secondary	Change from baseline in best-corrected visual acuity (BCVA) at distance		Baseline (Day 0), up to Day 180	No
Secondary	Proportion of subjects with closure of macular hole (MH), if present at baseline		Up to Day 180	No
Secondary	Proportion of subjects with nonsurgical resolution of VMT/sVMA		Up to Day 180	No
Secondary	Proportion of subjects experiencing pars plana vitrectomy (PPV) at Day 180		Day 180	No
Secondary	Change from baseline in central foveal thickness		Up to Day 180	No