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

Sponsor
EyeD Pharma
Study ID
NCT07036510
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TimoD implant — DRUG
    Consists of 1 TimoD implant administration in the study eye.
  • Injector system — DEVICE
    This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

Study Details

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.

Key Dates

First listed
Jun 25, 2025
Start date
Jun 12, 2025
Status verified
Jun 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: TimoD implant - Dose 1 (low dose)
    Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
  • Experimental: TimoD implant - Dose 2 (intermediate dose)
    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.
  • Experimental: TimoD implant - Dose 3 (high dose)
    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 Measure

Number (%) of participants experiencing adverse events [ Time Frame: From Screening (up to Day -41) to end of study (Month 13) ]

Central Contacts

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