Sustained-release TimoD (timolol) implant placed during cataract surgery for glaucoma or ocular hypertension
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
This trial tests whether a small TimoD timolol implant placed during cataract surgery is safe and well tolerated in people with glaucoma or ocular hypertension.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | EyeD Pharma Industry-sponsored |
| Locations | 1 site (Panama City) |
| Trial ID | NCT07036510 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial enrolls small cohorts to examine safety and tolerability of three dose ranges of the TimoD sustained-release timolol implant. The implant is placed in one eye at the time of uncomplicated cataract surgery using an investigational injector system and is designed to release timolol slowly for up to one year. Three dose groups (low, intermediate, high) will each include six participants who receive a single implant and are followed for systemic timolol levels, intraocular pressure, and ocular safety including implant placement and removal. The primary focus is on detecting safety signals and tolerability, with any intraocular pressure effects recorded as secondary observations.
Who should consider this trial
Good fit: Adults with open-angle glaucoma or ocular hypertension who are undergoing uncomplicated cataract surgery with intra-capsular IOL placement, able to give informed consent, and without beta-blocker hypersensitivity are ideal candidates.
Not a fit: Patients with known hypersensitivity or contraindications to beta-blockers, clinically significant ocular disease other than glaucoma or cataract, angle-closure glaucoma, or those unable to attend follow-up visits are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, the implant could deliver timolol for up to a year after cataract surgery, potentially reducing or eliminating the need for daily eye drops and improving medication adherence.
How similar studies have performed: Sustained-release intraocular implants for glaucoma (for example intracameral bimatoprost implants) have shown promise in lowering eye pressure, but a timolol implant like TimoD is a newer approach with limited published data.
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. * Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement. * successful, uncomplicated cataract surgery Exclusion Criteria: * Subjects with a history of hypersensitivity or contraindications to β- blockers. * Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure * Significant risks caused by washout of ocular hypotensive medications. * Clinically significant ocular pathology other than OHT, glaucoma and cataract
Where this trial is running
Panama City
- Panama Eye Center — Panama City, Panama (Recruiting)
Study contacts
- Study coordinator: EyeD Pharma
- Email: dpo@eyedpharma.com
- Phone: +3242299000
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.