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

March 22, 2024 updated by: EyeD Pharma

A First-In-Human, Open-Label, Dose Escalating, Non-Randomized Study to Assess the Safety and Tolerability of a New Timolol Sustained Release Intraocular Implant (TimoD) in Subjects With Primary Open Angle Glaucoma With Pseudophakia

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. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Timolol will be delivered through an investigational drug called 'TimoD implant'. This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system.

Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.

The Timolol will be released slowly through the implant for up to 1 year (main phase).

Approximately 1 year after the TimoD implant is placed into the eye and in absence of contraindications, the participants will be invited to continue the study in an extension phase. If the participants agree to enter the extension phase and the study investigator confirms it is safe for them, the TimoD implant will remain in the study eye for one additional year.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • CHU - Service d'Ophtalmologie
        • Principal Investigator:
          • Nathalie Collignon, Prof. MD.
  • Germany
      • Düsseldorf, Germany, 40212
        • Recruiting
        • Breyer, Kaymak & Klabe Augenchirurgie
        • Principal Investigator:
          • Karsten Klabe, MD.
      • Heidelberg, Germany, 69120
        • Not yet recruiting
        • Universitäts-Augenklinik Heidelberg
        • Principal Investigator:
          • Gerd Auffarth, Prof. MD.
      • Magdeburg, Germany, 39120
        • Recruiting
        • Universitätsaugenklinik Magdeburg
        • Principal Investigator:
          • Giulia Reineri, MD.
      • Sulzbach, Germany, 66280
        • Recruiting
        • Augenklinik Sulzbach
        • Principal Investigator:
          • Karl Boden, MD.
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitäts-Augenklinik Tübingen
        • Principal Investigator:
          • Bogomil Voykov, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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, at least 12 months after surgery.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Group 1: TimoD implant-Dose 1 (low dose)
Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
Drug: TimoD implant
Consists of 1 TimoD implant administration in the study eye
Other Names:
  • Intraocular implant releasing timolol
  • Investigational drug
Device: 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 Names:
  • ACCUJECT™ 2.2.-BL
  • Investigational device
Experimental: Group 2: 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, providing there are no safety issues in Group 1.
Drug: TimoD implant
Consists of 1 TimoD implant administration in the study eye
Other Names:
  • Intraocular implant releasing timolol
  • Investigational drug
Device: 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 Names:
  • ACCUJECT™ 2.2.-BL
  • Investigational device
Experimental: Group3: 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.
Drug: TimoD implant
Consists of 1 TimoD implant administration in the study eye
Other Names:
  • Intraocular implant releasing timolol
  • Investigational drug
Device: 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 Names:
  • ACCUJECT™ 2.2.-BL
  • Investigational device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of participants experiencing one or more serious adverse events (SAEs)
Time Frame: From screening visit (up to Day -41) to end of study (Week 108)
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
Time Frame: From screening visit (up to Day -41) to end of study (Week 108)
From screening visit (up to Day -41) to end of study (Week 108)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeD Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EyeD-010-003
  • 2020-002354-24 (EudraCT Number)
  • CIV-21-12-038426 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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