Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy.

Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Open Angle Glaucoma; Open Angle Glaucoma
• Intervention / Treatment: Device: Minimally Invasive Micro Sclerostomy Device

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, ≥ 40 years to ≤ 85 years old
2. Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy

3. Primary open angle glaucoma diagnosis based on:

   1. Visual field mean deviation of -3dB or worse and
   2. Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
4. Presence of healthy, free, and mobile conjunctiva in the target quadrant
5. Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy [GATT])
6. Subject is able and willing to attend all scheduled follow-up exams
7. Subject understands and signs the informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIMS® Device/Procedure Arm; Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.	Device: Minimally Invasive Micro Sclerostomy Device; During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.; Other Names: MIMS® Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate of the MIMS® device/procedure at 12 months after surgery	Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND; Using the same number or fewer topical IOP lowering medications	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Effectiveness Endpoint 1	Change in IOP (mmHg) from baseline to 12 months follow-up	12 months
Exploratory Effectiveness Endpoint 2	Change in IOP (% change) from baseline to 12 months follow-up	12 months
Exploratory Effectiveness Endpoint 3	Change in the number of IOP lowering topical medications from screening to 12 months follow-up	12 months
Exploratory Effectiveness Endpoint 4	Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up	12 months
Safety Outcome 1	Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period	12 months
Safety Outcome 2	Biomicroscopic slit lamp and ophthalmoscopy findings	12 months
Safety Outcome 3	Preservation of Best-Corrected Visual Acuity (BCVA)	12 months

Collaborators and Investigators

• Sponsor: Sanoculis Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 2, 2024
• First Submitted That Met QC Criteria: March 9, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Polypharmacy; Intraocular Pressure; Open Angle Glaucoma; MIGS; Minimally Invasive Glaucoma Surgery; MIMS; MTMT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: MMS-US-1

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.: No