Travoprost Implant for Glaucoma

Recruiting at 2 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Glaukos Corporation

Disqualifiers: Prior glaucoma surgery, 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

Compensation: Varies

Number of Visits: Unknown

610 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with open-angle glaucoma or ocular hypertension (high eye pressure). The goal is to assess the safety and effectiveness of a special implant containing the medicine travoprost (Gen 2 Travoprost Intracameral Implant) compared to standard eye drops. The trial includes different groups, with some participants receiving the implant and others using timolol eye drops, a common treatment. Participants should not have undergone certain eye surgeries previously. This study could help identify better methods to manage eye pressure and prevent vision loss. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potential advancements in eye care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the Gen 2 Travoprost Intracameral Implant is safe for treating glaucoma?

Research has shown that the second-generation Travoprost Intracameral Implant is generally well-tolerated. One study found that after three years, this implant effectively lowered intraocular pressure and received positive feedback from patients. Importantly, no serious safety issues emerged in this study, supporting the implant's safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Gen 2 Travoprost Intracameral Implant for glaucoma because it offers a novel delivery method compared to standard treatments like timolol eye drops. Unlike traditional eye drops that require daily administration, this implant delivers medication directly into the eye over an extended period, potentially improving adherence and reducing the burden on patients. Additionally, the implant utilizes a second-generation form of travoprost, which may enhance the effectiveness of lowering intraocular pressure, a key factor in managing glaucoma. This innovative approach could mean more consistent treatment and better long-term outcomes for patients.

What evidence suggests that the Gen 2 Travoprost Intracameral Implant could be an effective treatment for glaucoma?

Research has shown that the Gen 2 Travoprost Intracameral Implant, which trial participants may receive, can significantly reduce eye pressure, an important factor in treating glaucoma. In a study involving 54 eyes, the average eye pressure decreased from 19.6 mmHg to 13.1 mmHg after three months. Lowering this pressure helps prevent damage to the optic nerve, often caused by glaucoma. Early results suggest that the implant provides a strong and lasting reduction in eye pressure with just one use, making it a promising option for managing glaucoma. ^{1 2 3 5 6}

Who Is on the Research Team?

Luis G. Vargas, MD

Principal Investigator

Glaukos Corporation

Are You a Good Fit for This Trial?

This trial is for individuals with glaucoma or ocular hypertension. Participants should not have other eye conditions that could affect the study's outcome, and they must be willing to follow the trial procedures.

Inclusion Criteria

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

Exclusion Criteria

I have had glaucoma surgery in the eye being studied.

I have had argon laser treatment on my eye.

I have had a less invasive glaucoma surgery in my study eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 2 Treatment

Participants receive the second generation travoprost intracameral implant or timolol 0.5% eye drops BID and are followed for 36 months

36 months

Phase 3 Treatment

Participants receive the second generation travoprost intracameral implant or timolol 0.5% eye drops BID with exchange or sham procedures at months 12, 24, or 36, followed by 12 months of follow-up

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Gen 2 Travoprost Intracameral Implant

Trial Overview The study tests a second-generation Travoprost Intracameral Implant against Timolol eye drops (a standard treatment) and placebo drops. Some participants will undergo a sham procedure to compare results fairly.

How Is the Trial Designed?

Group I: Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm Experimental Treatment 1 Intervention

Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months

Group II: Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm Experimental Treatment 2 Interventions

Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months

Group III: Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm Experimental Treatment 2 Interventions

Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months

Group IV: Period 1 (Cohort A) Experimental Treatment 1 Intervention

Single-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months

Group V: Period 3 (Cohort Y) Timolol Arm Active Control 2 Interventions

Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months

Group VI: Period 3 (Cohort Z) Timolol Arm Active Control 2 Interventions

Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months

Group VII: Period 3 (Cohort X) Timolol Arm Active Control 2 Interventions

Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months

Group VIII: Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm Active Control 2 Interventions

Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months

Group IX: Period 2 (Cohort B) Timolol Arm Active Control 2 Interventions

Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11747201/

Travoprost Intracameral Implant in Eyes with Glaucoma or ... In the consistent cohort of eyes with 3-month follow-up data (n=54), mean IOP reduced from 19.6±3.8 mmHg preoperatively to 13.1±2.5 mmHg at 3 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07075718

Study Details | NCT07075718 | Phase 2/Phase 3 Trial to ... ... Glaucoma or Ocular Hypertension. Official Title. Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral ...

3. aaojournal.org aaojournal.org/article/S0161-6420(24)00161-1/fulltext

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 ...

4. glaucomatoday.com glaucomatoday.com/articles/2024-nov-dec-insert2/a-deep-dive-on-the-idosesupsup-tr-phase-2b-trial

A Deep Dive on the iDose® TR Phase 2b Trial iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular ...

5. researchgate.net researchgate.net/publication/388089621_Travoprost_Intracameral_Implant_in_Eyes_with_Glaucoma_or_Ocular_Hypertension_Early_Short-Term_Real-World_Outcomes

Travoprost Intracameral Implant in Eyes with Glaucoma or ... In the consistent cohort of eyes with 3-month follow-up data (n=54), mean IOP reduced from 19.6±3.8 mmHg preoperatively to 13.1±2.5 mmHg at 3 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07075718/phase-2-phase-3-trial-to-evaluate-the-safety-and-efficacy-of-the-second-generation-travoprost-intracameral-implant

Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy ... Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% ...