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Multicenter Glaucoma Study Investigating Standalone Canaloplasty (MAGIC)

Primary Purpose

Primary Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ab-interno canaloplasty utilizing the iTrack Advance device
Ab-interno canaloplasty utilizing the OMNI Surgical System
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: 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): Laser trabeculoplasty i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty iStent or iStent Inject within 180 days of the Screening Visit Endocyclophotocoagulation (ECP) or Micropulse laser Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve Prior canaloplasty (ab interno and ab externo) Prior goniotomy, or trabeculotomy (ab externo and ab interno) Hydrus microstent 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

Sites / Locations

  • Breyer Kaymak Klabe AugenchirurgieRecruiting
  • Manchester Royal Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iTrack Advance

OMNI Surgical System

Arm Description

Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.)

Ab-interno canaloplasty utilizing the OMNI Surgical System

Outcomes

Primary Outcome Measures

The mean change in unmedicated Intraocular pressure (IOP) at 12 months post-intervention compared to baseline
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)

Secondary Outcome Measures

Full Information

First Posted
March 14, 2023
Last Updated
June 24, 2023
Sponsor
Nova Eye, Inc.
Collaborators
Nova Eye Medical GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05786196
Brief Title
Multicenter Glaucoma Study Investigating Standalone Canaloplasty
Acronym
MAGIC
Official Title
Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTrack Advance
Arm Type
Active Comparator
Arm Description
Ab-interno canaloplasty utilizing the iTrack Advance microcatheter device (Nova Eye, Inc.)
Arm Title
OMNI Surgical System
Arm Type
Active Comparator
Arm Description
Ab-interno canaloplasty utilizing the OMNI Surgical System
Intervention Type
Device
Intervention Name(s)
Ab-interno canaloplasty utilizing the iTrack Advance device
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Intervention Type
Device
Intervention Name(s)
Ab-interno canaloplasty utilizing the OMNI Surgical System
Intervention Description
360 degree microcatheterization and viscodilation of Schlemm's canal
Primary Outcome Measure Information:
Title
The mean change in unmedicated Intraocular pressure (IOP) at 12 months post-intervention compared to baseline
Time Frame
12 months
Title
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): Laser trabeculoplasty i. Selective Laser Trabeculoplasty (SLT) conducted within 6-months of the Screening Visit ii. Prior Argon Laser Trabeculoplasty iStent or iStent Inject within 180 days of the Screening Visit Endocyclophotocoagulation (ECP) or Micropulse laser Trabeculectomy or other bleb forming procedure including Xen, Express, and glaucoma draining device/valve Prior canaloplasty (ab interno and ab externo) Prior goniotomy, or trabeculotomy (ab externo and ab interno) Hydrus microstent 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Pickrel
Phone
1-800-391-2316
Email
mpickrel@nova-eye.com
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
Breyer Kaymak Klabe Augenchirurgie
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karsten Klabe, MD
Facility Name
Manchester Royal Eye Hospital
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leon Au, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multicenter Glaucoma Study Investigating Standalone Canaloplasty

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