Primary Open-angle Glaucoma Clinical Trial
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
Verified date | March 2024 |
Source | EyeD Pharma |
Contact | EyeD Pharma |
Phone | +32 4 229 90 00 |
dpo[@]eyedpharma.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 18 |
Est. completion date | July 2027 |
Est. primary completion date | July 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 a2-agonists. - Subjects with a history of hypersensitivity or contraindications to ß-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. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU - Service d'Ophtalmologie | Liège | |
Germany | Breyer, Kaymak & Klabe Augenchirurgie | Düsseldorf | |
Germany | Universitäts-Augenklinik Heidelberg | Heidelberg | |
Germany | Universitätsaugenklinik Magdeburg | Magdeburg | |
Germany | Augenklinik Sulzbach | Sulzbach | |
Germany | Universitäts-Augenklinik Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
EyeD Pharma |
Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01841437 -
Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
|
N/A | |
Completed |
NCT01410188 -
Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
|
Phase 1/Phase 2 | |
Completed |
NCT02077231 -
Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
|
N/A | |
Recruiting |
NCT05557058 -
GORE Glaucoma Drainage Implant Clinical Study
|
N/A | |
Not yet recruiting |
NCT03924544 -
Decorin in Sub Scleral Trabeculectomy
|
Phase 1 | |
Active, not recruiting |
NCT03673644 -
Impact of Glaucoma and Visual Field Loss on Life Space
|
||
Completed |
NCT03365778 -
Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment
|
N/A | |
Completed |
NCT01915940 -
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
|
Phase 2 | |
Completed |
NCT03889652 -
Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction
|
||
Terminated |
NCT03273907 -
Post Approval Study of the CyPass System
|
N/A | |
Recruiting |
NCT03193333 -
PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
|
Phase 3 | |
Recruiting |
NCT03921931 -
Retinal Photoreceptor Outer Segment Length Before and After Light Stimulation - a Pilot Study
|
N/A | |
Not yet recruiting |
NCT04609345 -
Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
|
||
Recruiting |
NCT05264818 -
Assessment of Endothelial Glycocalyx in Patients With Primary Open-angle Glaucoma
|
||
Completed |
NCT04333433 -
PRESERFLO® MicroShunt Extension Study
|
||
Enrolling by invitation |
NCT02144103 -
Effectiveness and Safety of Adipose-Derived Regenerative Cells for Treatment of Glaucomatous Neurodegeneration
|
Phase 1/Phase 2 | |
Completed |
NCT01281020 -
Adherence With Fixed Versus Unfixed Glaucoma Therapy
|
||
Recruiting |
NCT04891588 -
Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
|
N/A | |
Completed |
NCT03145129 -
PAIR Study-PAP And IOP Relationship: Study 2
|
||
Completed |
NCT03104621 -
Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients
|
Phase 4 |