Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

NCT07074782 | Not Yet Recruiting

• 1 other identifier: ECR-GLC-2025-18
• Study Type: observational
• Target: 1,500
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (9)

• Intraocular pressure (IOP), measured using a Goldmann applanation tonometer, an iCare tonometer, or similar. Change in IOP value (mmHg).

  Change in IOP value (mmHg).

  6 months

• Visual field (VF) - Mean Deviation, measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar

  Evaluation of Change in Mean Deviation (MD, dB).

  6 months

• Visual Field - Pattern Standard Deviation, measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar.

  Evaluation of Pattern Standard Deviation (PSD, dB).

  6 months

• Visual Field - Glaucoma Progression Analysis (GPA), measured by automated perimetry testing devices, such as Haag-Streit Octopus, Zeiss Humphrey, or similar.

  Evaluation of Glaucoma Progression Analysis (GPA, %/year).

  6 months

• Optical Coherence Tomography - Change in Average GCL+IPL Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar.

  Evaluation of Change in Average GCL+IPL thickness (µm).

  6 months

• Optical Coherence Tomography - Average RNFL Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar.

  Evaluation of average RNFL thickness (µm).

  6 months

• Optical Coherence Tomography - Disc Rim Area, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar.

  Evaluation of Disc Rim Area (mm²).

  6 months

• Optical Coherence Tomography - Cup-to-disc Ratio, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar.

  Evaluation of Cup-to-disc ratio (average and vertical).

  6 months

• Optical Coherence Tomography - Central Subfield Thickness, measured by Heidelberg Spectralis, Zeiss Cirrus, or similar.

  Evaluation of Central Subfield Thickness (µm).

  6 months

Secondary Outcomes (4)

• 10 Visual Acuity, measured by Best Corrected Visual Acuity (BCVA) score, using Snellen and/or LogMar charts.

  6 months

• Adverse Events, as reported in patient's medical history.

  6 months

• Adherence to Study Treatment

  6 months

• Additional Glaucoma Interventions

  6 months

Other Outcomes (5)

• Retinal Cells apoptosis Detected by DARC Imaging

  6 months

• Vascular Outcomes - Change in the FAZ area (OCT-A parameter), measured by Zeiss Cirrus AngioPlex, or similar.

  6 months

• Vascular outcomes - Change in Peripapillary Vessel Density (OCT-A parameter), measured by Zeiss Cirrus AngioPlex, or similar.

  6 months

Study Arms (2)

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).

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1500 eyes (750 treated with prostaglandin analogues and 750 treated with a different IOP-lowering compound)

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

Sponsors & Collaborators

• European Vision Institute Clinical Research Network: collaborator
• Association for Innovation and Biomedical Research on Light and Image: lead

Study Sites (10)

Department of Ophthalmology University of Bonn

Bonn, Germany

Location

University Eye Hospital Leipzig

Leipzig, Germany

Location

Centre for Clinical Trials at San Paolo Hospital University of Milan

Milan, Italy

Location

Eye Unit, University Hospital Maggiore della Carità

Novara, Italy

Location

Centro de Oftalmologia Barraquer

Barcelona, Spain

Location

Retina Unit, Department of Ophthalmology, Bellvitge University Hospital

Barcelona, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

ICORG - Imperial College Ophthalmologic Research Group

London, United Kingdom

Location

NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust

London, United Kingdom

Location

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MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Ana S Silva, PhD

CONTACT

+351239480112; neuropa@aibili.pt

Liliana C Soares, MsC

CONTACT

+351239480105; lcarvalho@aibili.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-12

Locations

IT (2); ES (2); CH (1); GB (3); DE (2)