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

Phase 1

Recruiting

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: TimoD implant; Device: Injector system

• Registration Number: NCT07036510
• Lead Sponsor: EyeD Pharma

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-12
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TimoD implant - Dose 1 (low dose)	TimoD implant	Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
TimoD implant - Dose 1 (low dose)	Injector system	Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
TimoD implant - Dose 2 (intermediate dose)	TimoD implant	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.
TimoD implant - Dose 2 (intermediate dose)	Injector system	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.
TimoD implant - Dose 3 (high dose)	TimoD implant	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.
TimoD implant - Dose 3 (high dose)	Injector system	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.

Primary Outcome Measures

Name	Time	Method
Number (%) of participants experiencing adverse events	From Screening (up to Day -41) to end of study (Month 13)
Number (%) of participants experiencing adverse events of special interest (AESI)	From Screening (up to Day -41) to end of study (Month 13)

Trial Locations

Locations (1)

Panama Eye Center; 🇵🇦 Panama City, Panama