Primary Open-angle GlaucomaPhase 1NCT06321562
Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma
A Phase 1 study testing TimoD implant and Injector system in people with Primary Open-angle Glaucoma, run by EyeD Pharma at 5 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- TimoD implant and Injector system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesGermany
- Study dates
- 1 Mar 2023to 26 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Breyer, Kaymak & Klabe Augenchirurgie
Düsseldorf, 40212
Universitäts-Augenklinik Heidelberg
Heidelberg, 69120
Universitätsaugenklinik Magdeburg
Magdeburg, 39120
Augenklinik Sulzbach
Sulzbach, 66280
Universitäts-Augenklinik Tübingen
Tübingen, 72076
About this study
Official title: 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 (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.
Read the 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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- TimoD implant, Injector system
- Keywords
- Glaucoma, POAG
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimoD implantDrug
Also called Intraocular implant releasing timolol, Investigational drug
Consists of 1 TimoD implant administration in the study eye
Injector systemDevice
Also called ACCUJECT™ 2.2.-BL, Investigational 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: TimoD implant; Device: Injector system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants experiencing one or more serious adverse events (SAEs)
Measured: 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
Measured: From screening visit (up to Day -41) to end of study (Week 108)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Mar 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Why it stopped: The study was terminated early due to the difficulties to enrol participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeD Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321562
- Sponsor's protocol ID
- EyeD-010-003
- Other IDs
- 2024-511254-51-00, CIV-21-12-038426
- Status last verified
- Jul 2025
- First submitted
- 13 Mar 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06321562
- Acronym / sponsor ID
- EyeD-010-003
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- Glaucoma, POAG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to the difficulties to enrol participant
- Enrolment
- 1 participants (actual)
- Lead sponsor
- EyeD PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: TimoD implant-Dose 1 (low dose) | Experimental | Drug: TimoD implant, Device: Injector systemParticipants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1. |
| Group 2: TimoD implant-Dose 2 (intermediate dose) | Experimental | Drug: TimoD implant, Device: Injector systemParticipants 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. |
| Group3: TimoD implant-Dose 3 (high dose) | Experimental | Drug: TimoD implant, Device: Injector systemParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TimoD implantAlso: Intraocular implant releasing timolol, Investigational drugConsists of 1 TimoD implant administration in the study eye | 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 systemAlso: ACCUJECT™ 2.2.-BL, Investigational deviceThis 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. | Device | Group 1: TimoD implant-Dose 1 (low dose), Group 2: TimoD implant-Dose 2 (intermediate dose), Group3: TimoD implant-Dose 3 (high dose) |
Primary outcome
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)
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)
Results and safety
The study was stopped early (reason given: The study was terminated early due to the difficulties to enrol participant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TimoD implant and Injector system in people with Primary Open-angle Glaucoma, run by EyeD Pharma at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to the difficulties to enrol participant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.