Assessment of Patients Treated With JETREA® for Vitreomacular Traction

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02035748
First received: January 11, 2014
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Vitreomacular Traction
Vitreomacular Adhesion
Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in best-corrected visual acuity (BCVA) at distance [ Time Frame: Baseline (Day 0), up to Day 180 ] [ Designated as safety issue: No ]
  • Proportion of subjects with closure of macular hole (MH), if present at baseline [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]
  • Proportion of subjects with nonsurgical resolution of VMT/sVMA [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing pars plana vitrectomy (PPV) at Day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • Change from baseline in central foveal thickness [ Time Frame: Up to Day 180 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume
Other Name: JETREA®

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035748

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Danyel C Carr, MS, CCRA Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02035748     History of Changes
Other Study ID Numbers: M-13-056, 2013-005464-25
Study First Received: January 11, 2014
Last Updated: May 23, 2014
Health Authority: European Union: European Medicines Agency
Belgium: Ethics Committee
Canada: Ethics Review Committee
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Poland: Ethics Committee
Portugal: Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Alcon Research:
Vitreomacular traction
Symptomatic vitreomacular adhesion
Ocriplasmin
JETREA

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014