Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma

NCT06321562 | Terminated Phase 1 DMC

• 3 other identifiers: EyeD-010-0032024-511254-51-00CIV-21-12-038426
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia (currently present or to be performed during the concomitant implantation surgery in subjects with age-related cataract eligible to intra-capsular IOL placement). The main questions it aims to answer are how safe 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,
• how safe different doses of timolol are and how the body handles taking it,
• the amount of Timolol released in the bloodstream,
• if there is any positive effect on the pressure inside the eye.

Conditions

Primary Open-angle Glaucoma

Keywords

Glaucoma; POAG

Outcome Measures

Primary Outcomes (2)

• Number and proportion of participants experiencing one or more serious adverse events (SAEs)

  From screening visit (up to Day -41) to end of study (Week 108)

• Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group

  From screening visit (up to Day -41) to end of study (Week 108)

Study Arms (3)

Group 1: TimoD implant-Dose 1 (low dose)

EXPERIMENTAL

Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.

Drug: TimoD implant; Device: Injector system

Group 2: TimoD implant-Dose 2 (intermediate dose)

EXPERIMENTAL

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, providing there are no safety issues in Group 1.

Drug: TimoD implant; Device: Injector system

Group3: TimoD implant-Dose 3 (high dose)

EXPERIMENTAL

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.

Drug: TimoD implant; Device: Injector system

Interventions

TimoD implant DRUG

Consists of 1 TimoD implant administration in the study eye

Also known as: Intraocular implant releasing timolol, Investigational drug

Group 1: TimoD implant-Dose 1 (low dose); Group 2: TimoD implant-Dose 2 (intermediate dose); Group3: TimoD implant-Dose 3 (high dose)

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.

Also known as: ACCUJECT™ 2.2.-BL, Investigational device

Group 1: TimoD implant-Dose 1 (low dose); Group 2: TimoD implant-Dose 2 (intermediate dose); Group3: TimoD implant-Dose 3 (high dose)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent.
• In good general and mental health without ongoing clinically significant abnormalities in medical history.
• Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12 months.
• Subjects with IOP not adequately controlled with the standard medication.
• Pseudophakia.

You may not qualify if:

• Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or α2-agonists.
• Subjects with a history of hypersensitivity or contraindications to β-blockers.
• Significant risks caused by washout of ocular hypotensive medications.
• History of any glaucoma not specified as POAG.
• History of elevated IOP due to corticosteroid use.
• History of ocular trauma.

Sponsors & Collaborators

• EyeD Pharma: lead

Study Sites (5)

Breyer, Kaymak & Klabe Augenchirurgie

Düsseldorf, 40212, Germany

Location

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsaugenklinik Magdeburg

Magdeburg, 39120, Germany

Location

Augenklinik Sulzbach

Sulzbach, 66280, Germany

Location

Universitäts-Augenklinik Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: March 1, 2023
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)