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Assessment of Patients Treated With JETREA® for Vitreomacular Traction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02035748
First received: January 11, 2014
Last updated: August 19, 2016
Last verified: August 2016
  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
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: Baseline, Day 28 ] [ Designated as safety issue: No ]
    Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.


Secondary Outcome Measures:
  • Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance [ Time Frame: Baseline (Day 0), Day 28, Day 90, Day 180 ] [ Designated as safety issue: No ]
    BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.

  • Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline [ Time Frame: Day 28, Day 90, Day 180 ] [ Designated as safety issue: No ]
    The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.

  • Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA [ Time Frame: Baseline, Day 90, Day 180 ] [ Designated as safety issue: No ]
    Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.

  • Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.

  • Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT) [ Time Frame: Baseline (Day 0), Day 28, Day 180 ] [ Designated as safety issue: No ]
    Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.


Enrollment: 628
Study Start Date: April 2014
Study Completion Date: September 2015
Primary Completion Date: September 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
0.5 mg/0.2 mL solution for injection
Other Name: JETREA®

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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  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

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sr Clinical Manager, Ophtha-GCRA Alcon, a Novartis Company
  More Information

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
Results First Received: August 11, 2016
Last Updated: August 19, 2016
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 for Clinical Research
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 December 02, 2016