OMNI Surgical System for Glaucoma

(EVOLVE Trial)

Recruiting at 1 trial location

Overseen By Afua Ohene-Nyako, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sight Sciences, Inc.

Must be taking: Prostaglandin analogs

Disqualifiers: Other glaucoma, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2 Participants Needed

Trial Summary

What is the purpose of this trial?

A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)

Do I have to stop taking my current medications for the trial?

The trial requires participants to be on a topical prostaglandin F2 analog as monotherapy for at least 3 months before the screening. The protocol does not specify if you need to stop other medications, but it seems you must continue the prostaglandin treatment.

What data supports the idea that OMNI Surgical System for Glaucoma is an effective treatment?

The available research shows that the OMNI Surgical System is effective for treating open-angle glaucoma. Studies like the ROMEO and GEMINI studies report positive outcomes 12 months after surgery, indicating that the OMNI system helps manage glaucoma when combined with cataract surgery. These studies suggest that the OMNI system can be a useful option for patients with mild to moderate open-angle glaucoma, providing a less invasive alternative to more traditional surgeries. ^{1 2 3 4 5}

What safety data is available for the OMNI Surgical System for glaucoma?

The safety data for the OMNI Surgical System includes several studies: The ROMEO study and ROMEO 2 study provide 12-month safety outcomes for canaloplasty and trabeculotomy in open-angle glaucoma, either alone or combined with cataract surgery. The GEMINI study offers interim 6-month safety outcomes for canaloplasty and trabeculotomy combined with phacoemulsification in open-angle glaucoma. These studies indicate the system's safety in managing glaucoma. ^{1 2 5 6 7}

Is the OMNI Surgical System a promising treatment for glaucoma?

Yes, the OMNI Surgical System is a promising treatment for glaucoma. It offers a minimally invasive option that can help manage eye pressure in patients with different types of glaucoma, including congenital and open-angle glaucoma. Studies show it can be effective when used alone or with cataract surgery, providing a new option between eye drops and more invasive surgeries. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for people who have had cataract surgery (pseudophakic patients) and are now dealing with primary open-angle glaucoma, a common type of eye pressure problem. Participants should need additional treatment despite already using eye drops for glaucoma.

Inclusion Criteria

I have been using eye drops for glaucoma for at least 3 months.

Intraocular pressure (IOP) at the Screening visit of 20 mmHg or more and not exceeding 36 mmHg

I am 45 years old or older.

Exclusion Criteria

I have not had a retinal laser procedure in the last 3 months.

I had laser eye surgery for glaucoma less than 6 months ago.

I have a type of glaucoma that is not primary open-angle.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo canaloplasty and trabeculotomy using the OMNI Surgical System or receive standard medical care with Latanoprost and adjunctive medications

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• OMNI Surgical System

Trial Overview The study is testing the OMNI Surgical System, which is a new procedure to help lower eye pressure, against standard treatments like Latanoprost and other glaucoma medications. Patients will be randomly assigned to one of these two approaches.

Participant Groups

Group I: Surgical (OMNI Surgical System (OSS)) Active Control 1 Intervention

Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Group II: Standard Medical Care (SMC) Active Control 1 Intervention

Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator

OMNI Surgical System is already approved in United States for the following indications:

Approved in United States as OMNI Surgical System for:

• Primary Open-Angle Glaucoma

Who Is Running the Clinical Trial?

Sight Sciences, Inc.

Lead Sponsor

Trials

14

Recruited

1,000+

Findings from Research

The OMNI surgical system was successfully used to treat a 4-month-old infant with congenital glaucoma associated with Sturge-Weber syndrome, effectively controlling intraocular pressure (IOP) without additional medication over a 10-month follow-up period.

This case suggests that the OMNI system may offer advantages over traditional angle surgery techniques in managing childhood glaucomas, indicating a need for further research into its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Viscodilation of Schlemm's Canal and Collector Channels and 360° Ab-Interno Trabeculotomy for Congenital Glaucoma Associated with Sturge-Weber Syndrome. Porsia, L., Nicoletti, M.[2022]

In a study involving 81 patients with mild-to-moderate open-angle glaucoma, the OMNI system combined with cataract surgery achieved a primary success rate of 79% to 81% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mm Hg after 12 months.

The procedure resulted in significant IOP reduction (from 21.9 to 15.1 mm Hg in higher baseline IOP group) and a decrease in the number of medications needed, with adverse events being typical for cataract surgery, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. Hirsch, L., Cotliar, J., Vold, S., et al.[2021]

The OMNI® Surgical System for treating primary open-angle glaucoma is budget-neutral for a hypothetical US health plan covering 1 million Medicare lives, showing a total cost decrease of $35,362 over two years.

Using OMNI® without cataract surgery incurs no additional costs, while its use with cataract surgery results in minor cost savings, indicating its financial efficiency as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The budget impact of introducing the OMNI® surgical system to a United States health plan for managing mild-to-moderate primary open-angle glaucoma. Mader, G., Ghinelli, F., Torelli, F., et al.[2023]

In a study of 149 patients with mild-moderate open-angle glaucoma and cataracts, the combination of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system significantly reduced mean diurnal intraocular pressure (IOP) from 23.8 mmHg to 15.6 mmHg (a 35% reduction) over 12 months.

The procedure also led to an 80% reduction in the need for glaucoma medications, with 84.2% of eyes achieving over 20% IOP reduction and 76% maintaining IOP levels between 6-18 mmHg, all while demonstrating a strong safety profile with mostly mild and self-limited adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. Gallardo, MJ., Pyfer, MF., Vold, SD., et al.[2022]

In a study of 48 pseudophakic patients with mild to moderate open-angle glaucoma, the sequential procedures of canaloplasty followed by trabeculotomy using the OMNI system achieved a primary success rate of 73% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mmHg after 12 months.

The procedures not only significantly lowered mean IOP (from 21.8 to 15.6 mmHg) but also reduced the number of medications needed for IOP control, demonstrating both efficacy and a favorable safety profile with mostly mild adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: The ROMEO Study. Vold, SD., Williamson, BK., Hirsch, L., et al.[2021]

In a study of 136 patients with mild-to-moderate open-angle glaucoma, the OMNI surgical system achieved a primary success rate of 71% in reducing intraocular pressure (IOP) by at least 20% or maintaining IOP between 6 and 18 mmHg after 12 months.

The procedure significantly lowered mean IOP from 22.3 mmHg to 15.9 mmHg and reduced the average number of medications needed from 1.9 to 1.3, with mild and expected adverse events, indicating both safety and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study. Murphy Iii, JT., Terveen, DC., Aminlari, AE., et al.[2022]

In a study of 137 patients with mild to moderate open-angle glaucoma, the combination of 360° canaloplasty and 180° trabeculotomy significantly reduced intraocular pressure (IOP) by an average of 9.0 mmHg (38%) after 6 months, with 78% of patients being medication-free.

The procedure demonstrated a favorable safety profile, with only minor adverse events reported, such as transient hyphema (4.6%) and minimal IOP elevation (2%), and no cases of vision loss or need for secondary surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study. Gallardo, MJ., Sarkisian, SR., Vold, SD., et al.[2022]

The OMNI surgical system significantly reduced intraocular pressure (IOP) in patients with mild to moderate open-angle glaucoma, with mean IOP dropping from 24.6 mmHg at baseline to 14.9 mmHg after 24 months, achieving a reduction of over 20% in all treated eyes.

Patients also experienced a substantial decrease in medication use, with 57.7% of eyes being medication-free at 24 months, and the procedure demonstrated a favorable safety profile, with most adverse events resolving spontaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Trabeculotomy and Viscodilation of Schlemm's Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes. Klabe, K., Kaymak, H.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Combined Viscodilation of Schlemm's Canal and Collector Channels and 360° Ab-Interno Trabeculotomy for Congenital Glaucoma Associated with Sturge-Weber Syndrome. [2022]

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

Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The budget impact of introducing the OMNI® surgical system to a United States health plan for managing mild-to-moderate primary open-angle glaucoma. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study. [2022]

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

Canaloplasty and Trabeculotomy with the OMNI System in Pseudophakic Patients with Open-Angle Glaucoma: The ROMEO Study. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

A Multicenter 12-Month Retrospective Evaluation of Canaloplasty and Trabeculotomy in Patients with Open-Angle Glaucoma: The ROMEO 2 Study. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Standalone Trabeculotomy and Viscodilation of Schlemm's Canal and Collector Channels in Open-Angle Glaucoma Using the OMNI Surgical System: 24-Month Outcomes. [2022]