Early Feasibility, Open-Label, Dose-Escalating, Non-Randomized Study to Evaluate the Safety of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Panama
Panama Eye Center
RECRUITING
Panama City
Contact Information
Primary
EyeD Pharma
dpo@eyedpharma.com
+3242299000
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2027-01
Participants
Target number of participants: 18
Treatments
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.
Sponsors
Leads: EyeD Pharma

This content was sourced from clinicaltrials.gov