Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery
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 study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Timolol will be administered using an investigational drug product called the TimoD implant.
The implant will be placed in one eye (the study eye) using an instrument called an injector system (an investigational device). The implant procedure will be performed during cataract surgery.
Stage 1: Three dose levels of the TimoD implant (low, intermediate, and high) will be evaluated in three groups of six participants each. Participants will be assigned sequentially to a treatment group and will receive a single implant containing one of the three dose levels. Participants in Stage 1 will be followed for 1 year.
Stage 2: The same three dose levels of the TimoD implant will be evaluated further. In addition, a fourth treatment group receiving an approved control treatment (timolol eye drops) will be included. Six participants will be randomized to each treatment group. Participants in Stage 2 will be followed for 3 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: EyeD Pharma
- Phone Number: +3242299000
- Email: dpo@eyedpharma.com
Study Locations
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-
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Panama City, Panama
- Recruiting
- Panama Eye Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TimoD implant - Dose 1 (low dose) - Stages 1 and 2
In Stage 1, participants in Group 1 will be enrolled first and will receive a low-dose TimoD implant in the study eye on Day 1. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator).. |
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 Names:
Consists of 1 TimoD implant administration in the study eye.
Other Names:
|
|
Experimental: TimoD implant - Dose 2 (intermediate dose) - Stages 1 and 2
In Stage 1, 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. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator). |
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 Names:
Consists of 1 TimoD implant administration in the study eye.
Other Names:
|
|
Experimental: TimoD implant - Dose 3 (high dose) - Stages 1 and 2
In Stage 1, 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. In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator). |
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 Names:
Consists of 1 TimoD implant administration in the study eye.
Other Names:
|
|
Active Comparator: Timolol eye drops - Stage 2
In Stage 2, participants will be randomly assigned to 1 of 4 treatment groups (3 TimoD dose levels or active comparator)
|
Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stage 1: Number (%) of participants experiencing adverse events
Time Frame: From Screening (up to Day -41) to end of stage 1 (Month 13)
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From Screening (up to Day -41) to end of stage 1 (Month 13)
|
|
Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI)
Time Frame: From Screening (up to Day -41) to end of stage 1 (Month 13)
|
From Screening (up to Day -41) to end of stage 1 (Month 13)
|
|
Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP)
Time Frame: Month 3
|
Month 3
|
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Stage 2: Proportion of time-matched responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM and 10 AM)
Time Frame: Month 3
|
Month 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EyeD-010-006
- U1111-1317-3395 (Other Identifier: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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