A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma

NCT07009236 | Not Yet Recruiting

• 1 other identifier: STAR VII (ISM12)
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).

Conditions

Glaucoma

Keywords

MINIject

Outcome Measures

Primary Outcomes (1)

• Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader

  Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader.

  1 week

Study Arms (3)

Investigational device FG300X

ACTIVE COMPARATOR

One version of delivery tool

Device: MIGS

Investigational device FG300Y

ACTIVE COMPARATOR

One version of delivery tool

Device: MIGS

Investigational device FG300Z

ACTIVE COMPARATOR

One version of delivery tool

Device: MIGS

Interventions

MIGS DEVICE

Implant MINIject S+ in supraciliary space

Investigational device FG300X; Investigational device FG300Y; Investigational device FG300Z

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, 20 years of age or older
• Diagnosis of open angle glaucoma (OAG) in the study eye
• Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
• Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
• Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
• Maximal C/D ratio must be 0.9 in the study eye
• Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations
• Subjects must provide written informed consent prior to any study procedures
• Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
• Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:
• Capsulorhexis is intact and centered
• Posterior capsular bag is intact
• The IOL is well-centered in the capsular bag
• There is no evidence of zonular dehiscence/rupture
• The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy.

You may not qualify if:

• Any eye surgery that was performed \< 90 days before Screening/Baseline visit in the study eye
• Diagnosis of diabetes mellitus with HbA1C \>7%
• Known or suspected allergy or hypersensitivity to medical silicone
• Allergy to fluorescein
• Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant
• Central endothelial cell density (ECD) at Screening visit with a mean value \<1900 cells/mm2 or coefficient of variation (CV) of endothelium \>0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism
• Anticipated need for ocular surgery or retinal laser procedure in the study eye
• Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,
• Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation
• Central corneal thickness greater than 600 microns
• Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders)
• Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye
• Evidence of crystalline lens subluxation or luxation in the study eye
• Inability to perform Visual Field (VF) testing in either eye
• Evidence of vitreous loss in the anterior chamber in the study eye

Sponsors & Collaborators

• iSTAR Medical: lead

Study Sites (3)

Los Robles Vision d/b/a Centro Oftalmológico Robles

Santa Rosa de Copán, 41101, Honduras

Location

Colchester General Hospital

Colchester, CO45JL, United Kingdom

Location

St Thomas' Hospital

London, SE17EH, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Florence Defresne, PhD

CONTACT

003210771251; florence.defresne@istar-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: FG300X The distal extremity features a closed, blunt tip that opens via a hinge positioned on the upper side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Y The distal extremity features a closed, blunt tip that opens via a hinge positioned on the bottom side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.25 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Z The distal extremity features an open, blunt tip without hinge. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); HO (1)