MINIject™ Implant for Glaucoma

(STAR-V Trial)

Not currently recruiting at 37 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small device called the MINIject™ implant to determine if it can safely and effectively lower eye pressure in individuals with primary open-angle glaucoma, a common condition that can lead to vision loss. The implant aims to reduce intraocular pressure (the fluid pressure inside the eye) and potentially prevent further vision problems. This study targets individuals with glaucoma who have undergone cataract surgery and may require additional treatments like medication or surgery. Participants should not have certain types of glaucoma, eye inflammation, or significant vision disorders. The goal is to explore a new method for managing glaucoma and protecting vision. As an unphased trial, this study provides an opportunity to contribute to innovative research that could lead to new treatment options for glaucoma.

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 prior data suggests that the MINIject™ implant is safe for lowering intraocular pressure in glaucoma patients?

Research has shown that the MINIject™ implant is generally safe for people with primary open-angle glaucoma. Over two years, studies found that patients experienced a significant decrease in eye pressure and required fewer medications. The safety results from these studies are encouraging, indicating that the implant is well-tolerated. Most patients did not experience serious side effects, making MINIject™ a possible alternative to other glaucoma treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The MINIject™ Implant is unique because it offers a minimally invasive approach to treating glaucoma, targeting the drainage pathways of the eye to lower intraocular pressure. Unlike traditional treatments such as eye drops, laser therapy, or more invasive surgeries like trabeculectomy, the MINIject™ Implant is designed to be less intrusive and potentially more comfortable for patients. Researchers are excited about this treatment because it simplifies the procedure while aiming to provide long-lasting results, possibly reducing the need for ongoing medication and frequent doctor visits.

What evidence suggests that the MINIject™ implant is effective for lowering intraocular pressure in glaucoma?

Research has shown that the MINIject™ implant, which participants in this trial will receive, can effectively lower eye pressure in people with primary open-angle glaucoma. One study found that 89.4% of patients experienced a reduction in eye pressure of 20% or more after two years, and 37.9% no longer needed medication. Other findings indicated a long-term drop in eye pressure of 38% over five years, with 83% of patients experiencing significant improvement. Additionally, many patients had their eye pressure fall below 14 mmHg, a favorable level for managing glaucoma. These results suggest that the MINIject™ implant can help control eye pressure, offering potential relief for those with this type of glaucoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Sabine Glibert

Principal Investigator

iSTAR Medical

Are You a Good Fit for This Trial?

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 have had successful cataract surgery and now have an artificial lens.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Implant Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

iSTAR Medical

Lead Sponsor

Trials

11

Recruited

2,300+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11901049/

Two-Year Data on the Efficacy and Safety of the MINIject ... The results indicate that MINIject offers effective IOP reduction, along with a favorable safety profile, over the course of two years. Given ...

2. ajo.com ajo.com/article/S0002-9394(23)00517-2/fulltext

Two-Year Performance and Safety Results of the MINIject ... There were 89.4% of patients who achieved a ≥20% reduction in IOP compared with baseline, and 37.9% patients were medication-free at 2 years.

3. link.springer.com link.springer.com/article/10.1007/s40123-025-01221-z

Real-World Data of the First UK Series of MINIject ... The STAR-I trial demonstrated the efficacy of MINIject with a sustained mean IOP reduction to below 14 mmHg at 2 years, with almost 50% of ...

4. istar-medical.com istar-medical.com/5year/

iSTAR Medical's MINIject® demonstrates significant ... The efficacy results indicated a sustained and significant 38% reduction of IOP through to five years. Overall, 83% of patients achieved a >20% reduction in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40095611/

Two-Year Data on the Efficacy and Safety of the MINIject ... At 24 months, the mean IOP was 14.58 ± 4.55 on 0.69 ± 0.98 medications (p = 0.002). No difference in IOP was noted between the combined and the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07009236

A Study Evaluating the Safety and Efficacy of MINIject S+ in ... This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the ...