Travoprost Implant for Glaucoma

Recruiting at 28 trial locations

Overseen By Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ocular Therapeutix, Inc.

Must not be taking: Topical prostaglandins

Disqualifiers: Uncontrolled systemic disease, 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: 2

Duration: 12 weeks

83 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small device that releases medication inside the eye to help patients with high eye pressure due to glaucoma or ocular hypertension. The medication helps fluid drain from the eye, reducing pressure and preventing vision problems.

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

Yes, you will need to stop taking your current glaucoma medications as part of the study requirements, but only if the investigator believes it can be done safely.

What data supports the effectiveness of this drug for glaucoma?

The bimatoprost implant (Durysta) has been shown to effectively lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, as demonstrated in studies where it reduced IOP over a 4- to 6-month period. Additionally, a retrospective study found that most patients experienced a reduction in IOP after receiving the implant. ^{1 2 3 4 5}

Is the Travoprost Implant for Glaucoma safe for humans?

The bimatoprost implant, also known as Durysta, has been approved for reducing eye pressure in glaucoma patients and has been studied for safety. However, there have been reports of side effects like cystoid macular edema (swelling in the retina) in some cases. ^{1 2 3 4 5}

How is the Travoprost Implant for Glaucoma different from other glaucoma treatments?

The Travoprost Implant for Glaucoma is unique because it uses a biodegradable implant to slowly release medication directly into the eye, reducing intraocular pressure over several months without the need for daily eye drops. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT). Participants must be willing to stop their glaucoma medications as per study rules and not be at risk by doing so. Pregnant or breastfeeding individuals, those unresponsive to certain eye pressure-lowering drugs, or with uncontrolled diseases like severe diabetes are excluded.

Inclusion Criteria

Women who could become pregnant must have a negative pregnancy test before starting the study.

Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk

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

Exclusion Criteria

Eye drops for my condition did not work for me.

I do not have any uncontrolled illnesses like heart disease or diabetes.

I am not pregnant, breastfeeding, and if I can have children, I use birth control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) or a single injection of DurystaTM

12 weeks

Visits at Week 2, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Durysta, Bimatoprost Intracameral Implant 10 µg
• OTX-TIC high dose Travoprost Intracameral Implant
• OTX-TIC low dose Travoprost Intracameral Implant

Trial Overview The trial tests two doses of OTX-TIC Travoprost Intracameral Implant against a known treatment, Durysta Bimatoprost Implant. It aims to see how well these treatments lower eye pressure in patients with OAG or OHT over time and monitor safety.

Participant Groups

Group I: OTX-TIC Low Dose Experimental Treatment 1 Intervention

Travoprost Intracameral Implant low dose

Group II: OTX-TIC High Dose Experimental Treatment 1 Intervention

Travoprost Intracameral Implant high dose

Group III: Durysta Active Control 1 Intervention

Bimatoprost Intracameral Implant 10 µg

Who Is Running the Clinical Trial?

Ocular Therapeutix, Inc.

Lead Sponsor

Trials

55

Recruited

6,400+

Findings from Research

The bimatoprost implant (Durysta™) is a biodegradable drug delivery system that provides sustained release of bimatoprost to lower intraocular pressure (IOP) for 4 to 6 months, making it a convenient treatment option for patients with open angle glaucoma or ocular hypertension.

Approved in March 2020, the implant represents a significant advancement in glaucoma treatment, allowing for prolonged IOP control without the need for daily eye drops, and its clinical development is still ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. Shirley, M.[2020]

In a study of 122 eyes from 84 patients, bimatoprost sustained-release (SR) significantly reduced intraocular pressure (IOP) from 18.5 mmHg to 16.0 mmHg and decreased the number of required glaucoma medications from 2.1 to 1.2, indicating its efficacy in managing glaucoma.

Among 41 eyes from 31 patients with prior glaucoma surgeries, bimatoprost SR also reduced medication burden, showing a decrease from 1.9 to 1.0 medications, suggesting it is effective even for patients who have undergone previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery. Bowers, ME., Wong, MK., Ventimiglia, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2022]

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

Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2023]

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

Bimatoprost Implant: First Approval. [2020]

4. France pubmed.ncbi.nlm.nih.gov

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery. [2023]

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

Bilateral Cystoid Macular Edema Following Bimatoprost Implants. [2022]