MINIject™ Implant for Glaucoma

(STAR-V Trial)

Recruiting at 35 trial locations

Overseen By Joanna Walker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: iSTAR Medical

Disqualifiers: Angle closure glaucoma, Degenerative visual disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

975 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a small device called the MINIject™ implant, which is designed to help lower eye pressure in people with primary open-angle glaucoma. The device works by making it easier for fluid to drain from the eye, reducing pressure and potentially preventing vision loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the MINIject™ Implant treatment for glaucoma?

The MINIject™ Implant is a new type of glaucoma treatment designed to lower eye pressure. While specific data on MINIject™ is limited, similar implants like the ExPRESS have shown success in reducing eye pressure in patients with different types of glaucoma, suggesting potential effectiveness for MINIject™ as well. ^{1 2 3 4 5}

Is the MINIject™ Implant generally safe for humans?

The MINIject™ Implant has been studied for safety in humans with glaucoma, showing it is generally safe for use in patients with uncontrolled open-angle glaucoma. Additionally, studies in rabbits have evaluated its biocompatibility, indicating it integrates well with eye tissues. ^{1 5 6 7 8}

What makes the MINIject™ Implant treatment unique for glaucoma?

The MINIject™ Implant is unique because it is a minimally invasive device placed in the supraciliary space (between the eye's layers) to lower eye pressure in glaucoma patients. It is designed to be biocompatible, reducing the risk of fibrous tissue formation that can block drainage, which is a common issue with other implants. ^{1 2 5 6 9}

Research Team

Richard Beckman, MD

Principal Investigator

iSTAR Medical

Eligibility Criteria

This trial is for men and women aged 46 or older with primary open-angle glaucoma who have had successful cataract surgery. It's suitable for those needing medical therapy, laser treatment, or surgery for glaucoma. People with eye inflammation, infections, degenerative visual disorders, or other types of glaucoma cannot participate.

Inclusion Criteria

I am 46 years old or older.

I have primary open-angle glaucoma and can undergo treatment or surgery.

I'm sorry, but "Key" is not a screening criterion. It is not possible to provide a summary or rewrite without additional context. Please provide more information.

Exclusion Criteria

I have been diagnosed with a condition that is causing my vision to worsen over time.

I have a specific type of glaucoma.

I have a serious eye infection or inflammation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MINIject™ implant to lower intraocular pressure

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MINIject™ Implant

Trial Overview The MINIject™ Implant by iSTAR Medical is being tested to see if it can safely lower intraocular pressure in patients with primary open-angle glaucoma. The study aims to evaluate its effectiveness compared to standard treatments.

Participant Groups

Group I: Implant Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

iSTAR Medical

Lead Sponsor

Trials

11

Recruited

2,300+

Findings from Research

The Ex-PRESS miniature glaucoma implant showed minimal tissue reaction in a study involving 8 rabbits, with a thin fibrotic capsule forming around only 25% of the implant surface after 3 and 6 months.

The absence of inflammatory cells and obstructions in the device's lumina suggests that the implant allows for free fluid flow, indicating its potential efficacy in managing glaucoma with reduced inflammatory response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biocompatibility of the Ex-PRESS miniature glaucoma drainage implant. Nyska, A., Glovinsky, Y., Belkin, M., et al.[2019]

In a study involving 35 eyes from 34 patients with severe glaucoma, a new technique using a Baerveldt implant with a titrated absorbable ligature effectively reduced intraocular pressure (IOP) from a mean of 42.8 mm Hg preoperatively to a final mean of 13.8 mm Hg after an average follow-up of 13 months, representing a 67.8% reduction.

The technique resulted in a high success rate, with 82.9% of eyes achieving complete success in IOP control, although some complications like choroidal detachments and transient tube obstructions were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. Ortiz Arismendi, GE., Peña Valderrama, Cdel P., Albis-Donado, O.[2022]

In a study of 22 eyes from 20 patients with uncontrolled secondary glaucoma, significant reductions in intraocular pressure (IOP) were observed after surgery using the ExPRESS mini implant, indicating its efficacy in managing this condition.

The surgery not only lowered IOP but also reduced the need for local and total glaucoma therapy, suggesting that the ExPRESS implant can simplify treatment for patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of uncontrolled secondary glaucoma with ExPRESS glaucoma minishunt implantation]. Samková, K., Rejmont, L.[2018]

Ex-Press miniature implant surgery is a promising new option for treating primary open-angle glaucoma, but it is not recommended for narrow angle-closure glaucoma or cases with a high risk of scarring failure.

Further evidence-based research is necessary to evaluate the effectiveness and safety of Ex-Press implantation in other types of glaucoma, such as aphakia or pseudo-phakia glaucoma, secondary open-angle glaucoma, and refractory glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comment on indications of Ex-Press miniature implant surgery]. Zhang, XL., Ge, J.[2017]

The MINIject™ glaucoma implant demonstrated excellent biocompatibility and tissue integration in rabbit studies, with no significant adverse reactions observed over a 6-month period.

The implant showed minimal fibrous encapsulation and stable cellular colonization, which may help maintain its drainage function and support long-term intraocular pressure reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel suprachoroidal microinvasive glaucoma implant: in vivo biocompatibility and biointegration. Grierson, I., Minckler, D., Rippy, MK., et al.[2022]

The MINIject supraciliary drainage device significantly reduced intraocular pressure (IOP) in patients with uncontrolled open-angle glaucoma, achieving a mean reduction of 40.7% over 2 years, with 47.6% of patients medication-free at follow-up.

The study demonstrated a high success rate, with 100% of patients achieving at least a 20% reduction in IOP, and no serious adverse events reported, indicating the safety and efficacy of this microinvasive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. Denis, P., Hirneiß, C., Durr, GM., et al.[2022]

The MINIject glaucoma drainage system significantly reduced intraocular pressure (IOP) in patients with primary open-angle glaucoma, achieving a mean reduction of 9.0 mmHg (39.1%) after 6 months, with 87.5% of patients being medication-free.

The procedure was safe, with no serious adverse events related to the device, and common mild complications like anterior chamber inflammation and IOP elevation resolved without requiring additional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I). Denis, P., Hirneiß, C., Reddy, KP., et al.[2021]

The Baerveldt glaucoma implant (BGI) significantly reduced intraocular pressure (IOP) from an average of 31.8 mm Hg to 14.4 mm Hg over a mean follow-up of 38.4 months, demonstrating its long-term effectiveness in managing refractory glaucoma.

The modified surgical technique used with BGI resulted in a high surgical success rate, with a complete success probability of 93.4% at 1 year and 91.4% at 4 years, while also minimizing serious postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of a Modified Technique Using the Baerveldt Glaucoma Implant for the Treatment of Refractory Glaucoma. Marchini, G., Ceruti, P., Vizzari, G., et al.[2018]

In a study involving 31 patients with primary open-angle glaucoma, the MINIject device significantly reduced intraocular pressure (IOP) by an average of 40.2% after 6 months, fulfilling the primary endpoint of over 60% success rate.

The use of IOP-lowering medications decreased by 63.4%, with 55.2% of patients being medication-free at the 6-month mark, indicating both efficacy and a potential improvement in quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). García Feijoó, J., Denis, P., Hirneiß, C., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Biocompatibility of the Ex-PRESS miniature glaucoma drainage implant. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. [2022]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

[Management of uncontrolled secondary glaucoma with ExPRESS glaucoma minishunt implantation]. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Comment on indications of Ex-Press miniature implant surgery]. [2017]

5. England pubmed.ncbi.nlm.nih.gov

A novel suprachoroidal microinvasive glaucoma implant: in vivo biocompatibility and biointegration. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A First-in-Human Study of the Efficacy and Safety of MINIject in Patients with Medically Uncontrolled Open-Angle Glaucoma (STAR-I). [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term Outcomes of a Modified Technique Using the Baerveldt Glaucoma Implant for the Treatment of Refractory Glaucoma. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). [2022]