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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to lower eye pressure in individuals with open-angle glaucoma or ocular hypertension. Researchers aim to compare the effectiveness of tiny implants containing the medication Travoprost (a prostaglandin analog) with standard Timolol eye drops. Participants will receive either the implant with varying medication release rates or a sham surgery with Timolol drops. Individuals with open-angle glaucoma or ocular hypertension who use two or fewer eye pressure medications may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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 prior data suggests that the Travoprost intraocular implants are safe for treating glaucoma?

Research has shown that the Travoprost eye implant is generally safe. In one study, the most common side effects included eye inflammation and redness. Eye inflammation occurred in up to 5.1% of patients, while redness appeared in up to 3.0%. Some participants also experienced decreased clarity of vision.

Previous studies indicate that the Travoprost implant is well-tolerated overall. Travoprost already has FDA approval for other uses, supporting its safety. For those considering joining the trial, these findings suggest that the implant is relatively safe, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional glaucoma treatments that rely on daily eye drops, the G2-TR intraocular implant offers a new delivery method by releasing travoprost directly into the eye. This implant comes in two variants, each with a different elution rate, allowing for tailored medication release and potentially improving adherence and effectiveness. Researchers are excited because this approach could provide a more consistent therapeutic effect and reduce the burden of daily medication, which is a significant issue for many patients with glaucoma.

What evidence suggests that the Travoprost intraocular implant could be effective for glaucoma?

Research has shown that the Travoprost implant, which participants in this trial may receive, effectively lowers eye pressure in people with open-angle glaucoma or high eye pressure. One study found that the implant significantly reduced eye pressure for three months after just one treatment. Keeping eye pressure low is crucial to preventing vision loss from glaucoma. The implant works by slowly releasing Travoprost, a medication that lowers eye pressure. This method is promising as it could provide steady pressure control without the need for daily eye drops. Participants in the control group will receive sham surgery and active-comparator eye drops, specifically Timolol Maleate Ophthalmic Solution, 0.5%. ^{1 2 3 6 7}

Who Is on the Research Team?

Kerry Stephens, OD

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38423216/

Phase 3 Randomized Clinical Trial of the Safety and ... The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03868124

NCT03868124 | Clinical Study Comparing Two Models of a ... This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR-063 ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/218010Orig1s000MedR.pdf

218010Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov information, the benefit/risk of Travoprost intraocular implant for the treatment of elevated IOP in open-angle glaucoma or ocular.

4. ctv.veeva.com ctv.veeva.com/study/clinical-study-comparing-two-models-of-a-travoprost-intraocular-implant

Clinical Study Comparing Two Models of a Travoprost ... Phase III study to compare the safety and efficacy of intraocular implants containing Travoprost at two different elution rates versus ...

5. withpower.com withpower.com/trial/phase-3-glaucoma-open-angle-7-2018-b1c70

Travoprost Intraocular Implants for Glaucoma Research shows that the Travoprost Intraocular Implant effectively lowers intraocular pressure (the pressure inside the eye) in patients with open-angle ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/218010Orig1s000AdminCorres.pdf

218010Orig1s000 - accessdata.fda.gov evidence of clinical safety and efficacy of Travoprost Intraocular Implant ... travoprost intraocular implant in patients with primary open-angle glaucoma or ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT03868124/Prot_000.pdf

SOLUTION, USP, 0.5% NCT03868124 This clinical protocol will evaluate two versions of the Travoprost Intraocular Implant: Model G2TR- and Model G2TR . The implants are identical ...