Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

EyeD Pharma

Status and phase: Enrolling; Phase 1

Conditions: Glaucoma; Ocular Hypertension

Treatments: Device: Injector system; Drug: TimoD implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07036510

U1111-1317-3395 (Other Identifier)

EyeD-010-006

Details and patient eligibility

About

The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery.

The main questions it aims to answer are how safe are three different doses of the investigational drug is and how the body tolerates it.

The study will also check:

• how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
• if and the amount of Timolol released in the bloodstream,
• if there is any positive effect on the pressure inside the eye.

Full description

Timolol will be delivered through an investigational drug called 'TimoD implant'.

This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system. This procedure will be performed in conjunction with the cataract surgery.

Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.Participants will receive only one dose. The Timolol will be released slowly through the implant for up to 1 year.

Enrollment: 18 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Capable of giving signed informed consent.
• In good general and mental health without ongoing clinically significant abnormalities in medical history.
• Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
• successful, uncomplicated cataract surgery

Exclusion criteria

• Subjects with a history of hypersensitivity or contraindications to β- blockers.
• Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure
• Significant risks caused by washout of ocular hypotensive medications.
• Clinically significant ocular pathology other than OHT, glaucoma and cataract

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

TimoD implant - Dose 1 (low dose)

Experimental group

Description:

Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.

Treatment:

Drug: TimoD implant

Device: Injector system

TimoD implant - Dose 2 (intermediate dose)

Experimental group

Description:

Participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant and providing there are no safety issues in Group 1.

Treatment:

Drug: TimoD implant

Device: Injector system

TimoD implant - Dose 3 (high dose)

Experimental group

Description:

Participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2.

Treatment:

Drug: TimoD implant

Device: Injector system