Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

Starting soon

Conditions studied: Glaucoma

In brief

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 facts

Study ID

NCT07074782

Run by

Association for Innovation and Biomedical Research on Light and Image

People needed

1500

Starts

2026-05-01

Expected to finish

2026-06-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18+ years
• Established glaucoma diagnosis (primary open-angle glaucoma, normal tension Glaucoma, pseudoexfoliation glaucoma, pigmentary dispersion glaucoma) in either eye
• Visual field mean deviation (MD; location-weighted mean difference from average age-corrected visual field sensitivity) of 2 visual fields differing by no more than 3 dB, for a mean deviation of better than -6.0 dB, or by no more than 4 dB, for a mean deviation worse than -6.0 dB, as measured using Humphrey perimetry (or equivalent Haag-Streit / Octopus; in at least one eye; analogous to The United Kingdom Glaucoma Treatment Study)
• Treatment with either prostaglandin analogues only or another topically applied IOP-lowering compound only for at least 3 years
• Documented follow-up period of at least 3 years
• At least 6 patient visits documented over the follow-up period with readings of IOP, visual field, OCT
• No additional glaucoma intervention apart from laser trabeculoplasty and/or cataract surgery during the observational period

You may not qualify if…

• Follow-up period < 3 years
• Number of patient visits <6 visits
• Number of OCT, visual field readings during the observation period < 6
• Low compliance/therapy interruption
• Beginning of combination therapy of prostaglandin analogues and other IOP lowering eye drops during the observation period
• In case of glaucoma diagnosis in both eyes: different topical IOP-lowering treatment regimes (e.g. prostaglandin analogues in one eye and beta-adrenergic blocking agents in the fellow eye)
• Additional glaucoma intervention during the observational period other than laser trabeculoplasty and/or cataract surgery

Where it is running

• Department of Ophthalmology University of Bonn — Bonn, Germany
• University Eye Hospital Leipzig — Leipzig, Germany
• Centre for Clinical Trials at San Paolo Hospital University of Milan — Milan, Italy
• Eye Unit, University Hospital Maggiore della Carità — Novara, Italy
• Centro de Oftalmologia Barraquer — Barcelona, Spain
• Retina Unit, Department of Ophthalmology, Bellvitge University Hospital — Barcelona, Spain
• University Hospital Basel — Basel, Switzerland
• Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital — Liverpool, United Kingdom
• ICORG - Imperial College Ophthalmologic Research Group — London, United Kingdom
• NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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