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Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty (MAGIC)

Primary Purpose

Primary Open Angle Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Canaloplasty using the iTrack microcatheter with Healon GV Pro
Canaloplasty using the Omni surgical system with Healon GV Pro
Canaloplasty using the iTrack microcatheter with Healon Pro
Canaloplasty using the Omni surgical system with Healon Pro
Sponsored by
Nova Eye, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Canaloplasty

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with mild to moderate open angle Glaucoma.
  2. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB
  3. IOP < or = to 36 mmHG while on one to four ocular hypotensive medications
  4. Shaffer grade of > or = III in all four quadrants
  5. Able and willing to comply with the Protocol and follow up visits for 12 months

Exclusion Criteria:

  1. Laser trabeculoplasty other than selective laser trabeculoplasty (SLT)
  2. History of iStent or iStent inject within 180 days of the screening visit
  3. History of ECP or Micropulse laser
  4. Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves
  5. Prior canaloplasty (ab interno and ab externo)
  6. Prior goniotomy or trabeculotomy
  7. History of Hydrus microstent or suprachoroidal stent
  8. History of cataract surgery within 6 months of screening
  9. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma

Sites / Locations

  • Arizona Advanced Eye Research Institute
  • Beverly Hills Institute of Ophthalmology
  • Coastal Vision
  • Dean McGee Eye Institute
  • Cataract and Laser Institute of Southern Oregon
  • El Paso Eye Surgeons
  • Eye Centers of Racine and Kenosha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

iTrack canaloplasty microcatheter with Healon GV Pro

OMNI surgical system with Healon GV Pro

iTrack canaloplasty microcatheter with Healon Pro

OMNI surgical system with Healon Pro

Arm Description

Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)

Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)

Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)

Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)

Outcomes

Primary Outcome Measures

Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
IOP will be measured at each study visit using Goldmann applanation tonometry

Secondary Outcome Measures

Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.
Visual acuity at 12 months compared to baseline visual acuity
Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart

Full Information

First Posted
February 18, 2021
Last Updated
March 13, 2023
Sponsor
Nova Eye, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04769453
Brief Title
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty
Acronym
MAGIC
Official Title
Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty, Randomized, Controlled Trial: iTrack (Nova Eye Medical) Compared to Omni (Sight Sciences)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor-initiated, suspension of study due to modification of key parameters.
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
January 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Eye, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, multicenter, randomized, single-masked clinical trial to evaluate the effectiveness outcomes of canaloplasty performed as a standalone procedure with the iTrack microcatheter to the Omni surgical system, and to compare the effectiveness of two types of Ophthalmic Viscoelastic Device (OVD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Canaloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iTrack canaloplasty microcatheter with Healon GV Pro
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Arm Title
OMNI surgical system with Healon GV Pro
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon GV Pro (ophthalmic viscoelastic device)
Arm Title
iTrack canaloplasty microcatheter with Healon Pro
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the iTrack microcatheter (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Arm Title
OMNI surgical system with Healon Pro
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the OMNI surgical system (canaloplasty) with Healon Pro (ophthalmic viscoelastic device)
Intervention Type
Device
Intervention Name(s)
Canaloplasty using the iTrack microcatheter with Healon GV Pro
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Intervention Type
Device
Intervention Name(s)
Canaloplasty using the Omni surgical system with Healon GV Pro
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Intervention Type
Device
Intervention Name(s)
Canaloplasty using the iTrack microcatheter with Healon Pro
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Intervention Type
Device
Intervention Name(s)
Canaloplasty using the Omni surgical system with Healon Pro
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Primary Outcome Measure Information:
Title
Reduction in mean Intraocular pressure (IOP) and glaucoma medication use at 12 months post-intervention
Description
IOP will be measured at each study visit using Goldmann applanation tonometry
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complications intra-operatively and post-operatively associated with the iTrack canaloplasty microcatheter compared to complications intra-operatively and post-operatively with the OMNI surgical system.
Time Frame
12 months
Title
Visual acuity at 12 months compared to baseline visual acuity
Description
Best corrected visual acuity (BCVA) will be assessed using the standard Snellen eye chart
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with mild to moderate open angle Glaucoma. Visual Field test (Humphrey SITA standard 24-2) with mean deviation better than or equal to -12.0 dB IOP < or = to 36 mmHG while on one to four ocular hypotensive medications Shaffer grade of > or = III in all four quadrants Able and willing to comply with the Protocol and follow up visits for 12 months Exclusion Criteria: Laser trabeculoplasty other than selective laser trabeculoplasty (SLT) History of iStent or iStent inject within 180 days of the screening visit History of ECP or Micropulse laser Trabeculectomy or other bleb forming procedure including Xen, Express and glaucoma drainage device/valves Prior canaloplasty (ab interno and ab externo) Prior goniotomy or trabeculotomy History of Hydrus microstent or suprachoroidal stent History of cataract surgery within 6 months of screening Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma, pigmentary or pseudoexfoliative glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamil Patel, MD, MBA
Organizational Affiliation
Eye Physicians and Surgeons of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Advanced Eye Research Institute
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Beverly Hills Institute of Ophthalmology
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Coastal Vision
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Cataract and Laser Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97501
Country
United States
Facility Name
El Paso Eye Surgeons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Eye Centers of Racine and Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Multicenter Ab-interno Glaucoma Study Investigating Canaloplasty

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