Testing a new eye implant for glaucoma treatment
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
This study is testing a new eye implant that slowly releases medication to see if it can safely lower eye pressure in people with glaucoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | EyeD Pharma Industry-sponsored |
| Locations | 5 sites (Düsseldorf and 4 other locations) |
| Trial ID | NCT06321562 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of a Timolol releasing intraocular implant in patients with primary open-angle glaucoma and pseudophakia. Participants will receive the TimoD implant, which delivers Timolol slowly over a year, and the study will assess how well the implant is placed, the safety of different doses, and the implant's effect on eye pressure. The study involves three groups of participants receiving varying doses of the implant and includes a potential extension phase for continued observation.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with primary open-angle glaucoma who have not achieved adequate intraocular pressure control with standard medications and have pseudophakia.
Not a fit: Patients currently using systemic timolol or those with contraindications to beta-blockers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and sustained treatment option for patients with glaucoma.
How similar studies have performed: While the specific use of the TimoD implant is novel, similar approaches using sustained drug delivery systems in glaucoma treatment have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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.
Where this trial is running
Düsseldorf and 4 other locations
- Breyer, Kaymak & Klabe Augenchirurgie — Düsseldorf, Germany (Recruiting)
- Universitäts-Augenklinik Heidelberg — Heidelberg, Germany (Recruiting)
- Universitätsaugenklinik Magdeburg — Magdeburg, Germany (Recruiting)
- Augenklinik Sulzbach — Sulzbach, Germany (Recruiting)
- Universitäts-Augenklinik Tübingen — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: EyeD Pharma
- Email: dpo@eyedpharma.com
- Phone: +32 4 229 90 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.