Multicenter Glaucoma Study Investigating Standalone Canaloplasty (MAGIC)

Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)

A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: Ab-interno canaloplasty utilizing the iTrack Advance device; Device: Ab-interno canaloplasty utilizing the OMNI Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Pickrel; Phone Number: 1-800-391-2316; Email: mpickrel@nova-eye.com

Study Locations

• Germany
  • Düsseldorf, Germany
    • Recruiting
    • Breyer Kaymak Klabe Augenchirurgie
    • Contact: Karsten Klabe, MD
• Spain
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico San Carlos, Servicio de Oftalmologia
    • Contact: Jose Martinez de la Casa, MD
• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • Princess Alexandra Eye Pavilion, NHS Lothian
    • Contact: Andrew Tatham, MD
  • Liverpool, United Kingdom
    • Recruiting
    • St. Paul's Eye Unit, Liverpool University
    • Contact: Neeru Vallabh, PhD
  • Manchester, United Kingdom
    • Recruiting
    • Manchester Royal Eye Hospital
    • Contact: Leon Au, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects, 22 years or older at the time of surgery
• Diagnosed with mild to moderate primary open angle glaucoma
• Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy
• Intolerance to medical therapy OR need/willingness to reduce medications
• At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications
• At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 33 mmHg, and ≥ 3mmHg higher than medicated IOP
• Shaffer grade of ≥ 3 in all four quadrants
• Endothelial cell density >2000 (cells/mm2)
• Central corneal thickness ≥ 490µm and ≤ 600 µm
• Able and willing to comply with the study procedures and attend all follow-up visits
• Understands and signs the informed consent

Exclusion Criteria:

• Any of the following prior treatments for glaucoma (study eye):

  1. Laser trabeculoplasty

     i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty

  2. iStent or iStent Inject within 180 days of the Screening Visit
  3. Endocyclophotocoagulation (ECP) or Micropulse laser
  4. Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve
  5. Prior canaloplasty (ab interno and ab externo)
  6. Prior goniotomy, or trabeculotomy (ab externo and ab interno)
  7. Hydrus microstent
  8. Suprachoroidal stent (e.g., Cypass, iStent Supra)
• Concurrent IOP-lowering procedure other than use of the iTrack Advance canaloplasty device OR the OMNI Surgical System at the time of surgery (e.g., ECP, CPC, etc.)
• Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary glaucoma or pseudoexfoliative glaucoma
• Cataract surgery within 6 months of the Screening Visit in the study eye
• History of fellow eye with cataract surgery within 30 days of Screening
• Subjects at significant risk by a washout of ocular hypotensive medication, and/or subjects where the unmedicated IOP is expected to exceed the upper limit of 33 mmHg
• Use of systemic medications (either current, within 30 calendar days of Screening exam, or anticipated) that may cause an increase in IOP, (e.g., systemic steroids including inhaled and oral steroids used on a regular basis)
• Ocular and/or systemic diseases that could affect the corneal endothelium (such as corneal endothelial dystrophy, intraocular inflammation and infection, or congenital abnormalities)
• History of penetrating keratoplasty or another corneal transplant
• BCVA of 20/200 or worse in the fellow eye not due to cataract
• Previous treatment with OMNI or iTrack (Note: permitted if fellow eye only was treated)
• BCVA of 20/50 or worse in the study eye not due to posterior capsular opacification

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iTrack Advance; Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.)	Device: Ab-interno canaloplasty utilizing the iTrack Advance device; 360 degree microcatheterization and viscodilation of Schlemm's canal
Active Comparator: OMNI Surgical System; Ab-interno canaloplasty utilizing the OMNI Surgical System	Device: Ab-interno canaloplasty utilizing the OMNI Surgical System; 360 degree microcatheterization and viscodilation of Schlemm's canal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of eyes achieving a 20% or greater reduction in unmedicated Intraocular pressure (IOP) at 12 months compared to baseline and without any other intervention (medication or secondary surgery)	12 months
The mean change in unmedicated Intraocular pressure (IOP) at 12 months post-intervention compared to baseline	12 months

Collaborators and Investigators

• Sponsor: Nova Eye, Inc.
• Collaborators: Nova Eye Medical GmbH
• Investigators: Principal Investigator: Shamil Patel, MD, MBA, Eye Physicians and Surgeons of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Canaloplasty
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: NE 05021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes