Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
NCT ID: NCT07036510
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2025-06-12
2027-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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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.
TimoD implant
Consists of 1 TimoD implant administration in the study eye.
Injector system
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.
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.
TimoD implant
Consists of 1 TimoD implant administration in the study eye.
Injector system
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.
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.
TimoD implant
Consists of 1 TimoD implant administration in the study eye.
Injector system
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.
Interventions
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TimoD implant
Consists of 1 TimoD implant administration in the study eye.
Injector system
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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EyeD Pharma
INDUSTRY
Responsible Party
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Locations
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Panama Eye Center
Panama City, , Panama
Countries
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Central Contacts
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Other Identifiers
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U1111-1317-3395
Identifier Type: OTHER
Identifier Source: secondary_id
EyeD-010-006
Identifier Type: -
Identifier Source: org_study_id
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