Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Study ID
NCT07074782
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to evaluate whether prostaglandin analogue eye drops have a direct neuroprotective effect on retinal ganglion cells - beyond their intraocular pressure (IOP)-lowering effect - in adult patients with glaucoma or ocular hypertension. The study includes individuals diagnosed with glaucoma (any sex/gender, adult age groups) undergoing standard clinical treatment. The main questions it aims to answer are: * Do prostaglandin analogues provide a neuroprotective effect on retinal ganglion cells that is independent of their IOP-lowering properties? * Should prostaglandin analogues be promoted/favoured over other IOP-lowering compounds for long-term glaucoma management? Researchers will compare an interventional group, which consist of 750 eyes treated with prostaglandin analogues (e.g., latanoprost, travoprost, tafluprost, bimatoprost, unoprostone), with a control group, which consist of 750 eyes treated with non-prostaglandin IOP-lowering compounds (e.g., timolol, dorzolamide, brimonidine, netarsudil) to see if treatment with prostaglandin analogues is associated with better retinal ganglion cell survival over a period of 3 years (36 months). Data will be collected from individuals who had at least 36 months of documented follow-up, with clinical data available at approximately 3, 6, 12, 24, and 36 months. Eligible individuals must have been treated with either prostaglandin analogues or other intraocular pressure (IOP)-lowering agents as part of routine clinical care. The data to be obtained from medical records will include at least: * Intraocular pressure readings * Visual field testing * OCT measures * Visual acuity * Adverse events * Treatment adherence/compliance * Additional glaucoma interventions

Key Dates

First listed
Jul 20, 2025
Start date
May 31, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Control Group (Non-Prostaglandin IOP-lowering compound)
    750 eyes treated with intraocular pressure-lowering compounds that do not belong to the prostaglandin analogue class. These treatments may include beta-adrenergic blocking agents (e.g., timolol, betaxolol), carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide), alpha-2 adrenergic agonists (e.g., brimonidine) or rho kinase inhibitors (e.g., netarsudil).
  • Arm: Interventional group (prostaglandin analogues)
    750 eyes treated with any prostaglandin analogue, such as latanoprost (e.g., Xalatan® 50 µg/mL, Pfizer), travoprost, tafluprost, bimatoprost, or unoprostone.

Primary Outcome Measure

Intraocular pressure (IOP), measured using a Goldmann applanation tonometer, an iCare tonometer, or similar. Change in IOP value (mmHg). [ Time Frame: 6 months ]

Central Contacts

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