Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

NCT02322229 | Completed Phase 4 Results

• 1 other identifier: RTA255-P001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitreomacular Traction; Vitreomacular Adhesion

Keywords

VMT; sVMA; vitrectomy; ocriplasmin

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA 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 according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. 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. One eye (study eye) contributed to the analysis.

  Day 28

Secondary Outcomes (5)

• Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180

  Baseline (Day 0), Day 7, Day 28, Day 90, Day 180

• Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)

  Day 7, Day 28, Day 90, Day 180

• Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180

  Baseline (Day 0), Day 7, Day 90, Day 180

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

  Day 180

• Change From Baseline in Central Foveal Thickness at Days 28 and 180

  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 (IVT) injection

Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume

Interventions

Ocriplasmin 0.125 mg in a 0.1 mL volume DRUG

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 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.
• Willing and able to attend all study visits.

You may not qualify if:

• Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, 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 in either eye.
• Participation in any interventional clinical trial within 30 days prior to baseline.
• Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
• Broad VMT/VMA \> 1500 microns at baseline in the study eye.
• History of vitrectomy in the study eye.
• History of laser photocoagulation to the macula in the study eye.
• Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period.
• Macular hole of \> 400 microns diameter in the study eye.
• High myopia in the study eye.
• Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability.
• Aphakia in the study eye.
• History of retinal detachment in the study eye.
• Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Laboratories (Australia) for Trial Locations

New South Wales, 2113, Australia

Location

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: Worldwide Medical Affairs Director, GMA Retina Lucentis
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Associate Dir of Operations, Ophthalmology, GMA

  Alcon, A Novartis Division

  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: December 17, 2014
• First Posted: December 23, 2014
• Study Start: May 26, 2015
• Primary Completion: December 11, 2015
• Study Completion: May 9, 2016
• Last Updated: August 21, 2018
• Results First Posted: July 23, 2018

Record last verified: 2017-10

Locations

AU (1)