Travoprost Intraocular Implants for Glaucoma

Overseen By Long Doan, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Glaukos Corporation

Disqualifiers: Corneal inflammation, Retinal disorders, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 10

Duration: 3 months

560 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing tiny devices placed inside the eye that release Travoprost slowly. It targets patients with high eye pressure due to open-angle glaucoma or ocular hypertension. Travoprost helps drain excess fluid from the eye, while Timolol reduces fluid production.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants can be on zero to two ocular hypotensive medications before the procedure.

What data supports the effectiveness of the Travoprost Intraocular Implant for treating glaucoma?

Research shows that the Travoprost Intraocular Implant effectively lowers intraocular pressure (the pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension, reducing the need for other eye pressure-lowering medications and improving treatment adherence. ^{1 2 3 4 5}

How is the G2TR intraocular implant containing travoprost different from other glaucoma treatments?

The G2TR intraocular implant is unique because it delivers travoprost directly inside the eye, potentially offering a more consistent and long-term reduction in intraocular pressure (IOP) compared to traditional eye drops, which are applied topically and may have variable absorption. ^{3 4 6 7 8}

Research Team

Kerry Stephens, OD

Principal Investigator

Glaukos Corporation

Eligibility Criteria

This trial is for people with a cup-to-disc ratio of 0.8 or less, who are on up to two glaucoma medications, and have been diagnosed with open-angle glaucoma or ocular hypertension. It's not for those with active corneal inflammation/edema or retinal disorders unrelated to glaucoma.

Inclusion Criteria

I have been diagnosed with open-angle glaucoma or high eye pressure.

C/D ratio ≤ 0.8

I am using up to two eye pressure-lowering medications.

Exclusion Criteria

I have active inflammation or swelling in my cornea.

I have a retinal disorder not related to glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a Travoprost intraocular implant or Timolol eye drops

3 months

Day 10, Week 6, Month 3 visits for IOP measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly visits for IOP measurements

Treatment Details

Interventions

• G2TR intraocular implant containing travoprost
• Timolol Maleate Ophthalmic Solution, 0.5% (Timolol)

Trial Overview The study compares two versions of a Travoprost-releasing eye implant (G2-TR) against Timolol eye drops in reducing high pressure inside the eyes caused by glaucoma or hypertension. Participants will be randomly assigned to receive one of these treatments.

Participant Groups

Group I: Implant Group 2 Experimental Treatment 1 Intervention

G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.

Group II: Implant Group 1 Experimental Treatment 1 Intervention

G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.

Group III: Control Group Active Control 1 Intervention

Sham surgery + active-comparator eye drops

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School

References

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

Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1). [2021]

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

Effects of latanoprost and unoprostone when used alone or in combination for open-angle glaucoma. [2019]

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

Effects of travoprost on aqueous humor dynamics in patients with elevated intraocular pressure. [2018]

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

Efficacy and safety of latanoprost versus travoprost in exfoliative glaucoma patients. [2018]

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

Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2023]

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

Estimating the long-term visual field consequences of average daily intraocular pressure and variance : a clinical trial comparing timolol, latanoprost and travoprost. [2018]

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

Safety and efficacy of travoprost solution for the treatment of elevated intraocular pressure. [2020]

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

Efficacy and safety of a systematic switch from latanoprost to travoprost in patients with glaucoma. [2018]