Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues
NCT ID: NCT07074782
Last Updated: 2025-12-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
1500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2026-01-31
Study Completion Date
2026-06-30
Brief Summary
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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
* 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
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Detailed Description
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Glaucoma is among the most prevalent causes of irreversible blindness and is characterized by a progressive, irreversible degeneration of the retinal ganglion cells. Elevated intraocular pressure (IOP) is the most important glaucoma risk factor and the only risk factor that is readily modifiable with established treatment options, which include pharmacological approaches, laser treatment, and surgery. However, in many patients the disease progresses even after IOP is effectively lowered. Hence, neuroprotective treatment approaches that go beyond IOP lowering are needed.
Prostaglandin analogue eye drops reduce IOP by increasing uveoscleral outflow and are a well-established treatment option in ocular hypertension and glaucoma. Animal studies suggest that prostaglandin analogues may have a direct neuroprotective effect on retinal ganglion cells in addition to the effect mediated by IOP lowering. Proposed mechanisms of action include inhibiting of caspase-3 and cyclooxygenase as well as activation of polypeptide 2B1 and Klotho protein. However, this proposed additional, direct neuroprotective effect has not yet been tested in human patients. The viability and functional status of the retinal ganglion cells in glaucoma can be assessed by morphological readings, the standard nowadays being various optical coherence tomography modalities, and by visual field testing. Detection of Apoptosing Retinal Cells (DARC) is another, relatively novel technology that allows for quantification of retinal ganglion cell death, presumably on a much shorter time scale.
This is an observational, retrospective and longitudinal clinical study, according to the normal clinical practice.
This study aims to evaluate prostaglandin analogues neuroprotective effect on retinal ganglion cells apart from intraocular pressure (IOP)-lowering over a period of 3 years (36 months) and whether treatment of ocular hypertension and glaucoma participants with prostaglandin analogues should be promoted/ favoured over other IOP-lowering compounds. It will have a follow-up at 3, 6, 12, 24, and 36 months in eyes with glaucoma treated with prostaglandin analogues or a different topically applied compound.
Prostaglandin analogue eye drops reduce IOP by increasing uveoscleral outflow and are a well-established treatment option in ocular hypertension and glaucoma. Animal studies suggest that prostaglandin analogues may have a direct neuroprotective effect on retinal ganglion cells in addition to the effect mediated by IOP lowering. Proposed mechanisms of action include inhibiting of caspase-3 and cyclooxygenase as well as activation of polypeptide 2B1 and Klotho protein. However, this proposed additional, direct neuroprotective effect has not yet been tested in human patients. The viability and functional status of the retinal ganglion cells in glaucoma can be assessed by morphological readings, the standard nowadays being various optical coherence tomography modalities, and by visual field testing. Detection of Apoptosing Retinal Cells (DARC) is another, relatively novel technology that allows for quantification of retinal ganglion cell death, presumably on a much shorter time scale.
This is an observational, retrospective and longitudinal clinical study, according to the normal clinical practice.
This study aims to evaluate prostaglandin analogues neuroprotective effect on retinal ganglion cells apart from intraocular pressure (IOP)-lowering over a period of 3 years (36 months) and whether treatment of ocular hypertension and glaucoma participants with prostaglandin analogues should be promoted/ favoured over other IOP-lowering compounds. It will have a follow-up at 3, 6, 12, 24, and 36 months in eyes with glaucoma treated with prostaglandin analogues or a different topically applied compound.
Conditions
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Glaucoma
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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European Vision Institute Clinical Research Network
NETWORK
Sponsor Role
collaborator
Association for Innovation and Biomedical Research on Light and Image
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Department of Ophthalmology University of Bonn
Bonn, , Germany
Site Status
University Eye Hospital Leipzig
Leipzig, , Germany
Site Status
Centre for Clinical Trials at San Paolo Hospital University of Milan
Milan, , Italy
Site Status
Eye Unit, University Hospital Maggiore della Carità
Novara, , Italy
Site Status
Centro de Oftalmologia Barraquer
Barcelona, , Spain
Site Status
Retina Unit, Department of Ophthalmology, Bellvitge University Hospital
Barcelona, , Spain
Site Status
University Hospital Basel
Basel, , Switzerland
Site Status
Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital
Liverpool, , United Kingdom
Site Status
ICORG - Imperial College Ophthalmologic Research Group
London, , United Kingdom
Site Status
NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
London, , United Kingdom
Site Status
Countries
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Germany
Italy
Spain
Switzerland
United Kingdom
Central Contacts
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Facility Contacts
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Karl Mercieca
Role: primary
Jan Darius Unterlauff
Role: primary
Luca Rossetti
Role: primary
Alessandro Rabiolo
Role: primary
Silvia S Moreno
Role: primary
Tim J Enz
Role: primary
Eduardo Normando
Role: primary
HARI JAYARAM
Role: primary
References
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BACKGROUND
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Harper MM, Boese EA, Kardon RH, Ledolter J, Kuehn MH. High Correlation between Glaucoma Treatment with Topical Prostaglandin Analogs and BDNF Immunoreactivity in Human Retina. Curr Eye Res. 2021 May;46(5):739-745. doi: 10.1080/02713683.2020.1822417. Epub 2020 Sep 27.
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Other Identifiers
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ECR-GLC-2025-18
Identifier Type: -
Identifier Source: org_study_id
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