Assessment of Patients Treated With JETREA® for Vitreomacular Traction

NCT02035748 | Completed Phase 4 Results

• 2 other identifiers: M-13-0562013-005464-25
• Study Type: interventional
• Target: 628
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitreomacular Traction; Vitreomacular Adhesion

Keywords

Vitreomacular traction; Symptomatic vitreomacular adhesion; Ocriplasmin; JETREA

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline, Day 28

Secondary Outcomes (5)

• Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance

  Baseline (Day 0), Day 28, Day 90, Day 180

• Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline

  Day 28, Day 90, Day 180

• Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA

  Baseline, Day 90, Day 180

• Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180

  Day 180

• Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)

  Baseline (Day 0), Day 28, Day 180

Study Arms (1)

Ocriplasmin

EXPERIMENTAL

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

Drug: Ocriplasmin

Interventions

Ocriplasmin DRUG

0.5 mg/0.2 mL solution for injection

Also known as: JETREA®

Ocriplasmin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Interventions

microplasmin; Plasminogen

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Beta-Globulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Protein Precursors

Results Point of Contact

• Title: EMEA Medical Affairs Lead, Pharma
• Organization: Alcon, a Novartis company

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr Clinical Manager, Ophtha-GCRA

  Alcon, a Novartis Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2014
• First Posted: January 14, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-08