Multicenter Glaucoma Study Investigating Standalone Canaloplasty

Primary Open Angle Glaucoma Clinical Trial

— MAGIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786196
• Other study ID #: NE 05021
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Nova Eye, Inc.
• Contact: Mike Pickrel
• Phone: 1-800-391-2316
• Email: mpickrel[@]nova-eye.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• Ab-interno canaloplasty utilizing the iTrack Advance device
360 degree microcatheterization and viscodilation of Schlemm's canal
• Ab-interno canaloplasty utilizing the OMNI Surgical System
360 degree microcatheterization and viscodilation of Schlemm's canal

Locations

Country	Name	City	State
Germany	Breyer Kaymak Klabe Augenchirurgie	Düsseldorf
Spain	Hospital Clinico San Carlos, Servicio de Oftalmologia	Madrid
United Kingdom	Princess Alexandra Eye Pavilion, NHS Lothian	Edinburgh
United Kingdom	St. Paul's Eye Unit, Liverpool University	Liverpool
United Kingdom	Manchester Royal Eye Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Nova Eye, Inc.	Nova Eye Medical GmbH

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in unmedicated Intraocular pressure (IOP) at 12 months post-intervention compared to baseline		12 months
Primary	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