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GlaucomaNEUROPANCT07074782

Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues

An observational study of Glaucoma, run by Association for Innovation and Biomedical Research on Light and Image at 10 sites in 5 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
How many people
1,500 participants
Where
10 sitesin 5 countries
Study dates
May 2026to Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Ana S Silva, PhD contact

+351239480112

neuropa@aibili.pt

Liliana C Soares, MsC contact

+351239480105

lcarvalho@aibili.pt

10 sites in 5 countries

United Kingdom3 sites
  • Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital

    Liverpool

  • ICORG - Imperial College Ophthalmologic Research Group

    London

    Eduardo Normando

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

    London

    HARI JAYARAM

Other trials in United Kingdom

Germany2 sites
  • Department of Ophthalmology University of Bonn

    Bonn

    Karl Mercieca

  • University Eye Hospital Leipzig

    Leipzig

    Jan Darius Unterlauff

Other trials in Germany

Italy2 sites
  • Centre for Clinical Trials at San Paolo Hospital University of Milan

    Milan

    Luca Rossetti

  • Eye Unit, University Hospital Maggiore della Carità

    Novara

    Alessandro Rabiolo

Other trials in Italy

Spain2 sites
  • Centro de Oftalmologia Barraquer

    Barcelona

  • Retina Unit, Department of Ophthalmology, Bellvitge University Hospital

    Barcelona

    Silvia S Moreno

Other trials in Spain

Switzerland1 site
  • University Hospital Basel

    Basel

    Tim J Enz

Other trials in Switzerland

About this study

Official title: Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues: NEUROPA - a Retrospective Cohort Study

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?
Read more

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
Read the detailed description

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.

Conditions
Glaucoma
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07074782
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in IOP value (mmHg).

    Measured: 6 months

  2. 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).

    Measured: 6 months

  3. 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).

    Measured: 6 months

  4. 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).

    Measured: 6 months

  5. 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).

    Measured: 6 months

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

    Evaluation of average RNFL thickness (µm).

    Measured: 6 months

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

    Evaluation of Disc Rim Area (mm²).

    Measured: 6 months

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

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

    Measured: 6 months

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

    Evaluation of Central Subfield Thickness (µm).

    Measured: 6 months

Secondary outcomes (4)
  1. 10 Visual Acuity, measured by Best Corrected Visual Acuity (BCVA) score, using Snellen and/or LogMar charts.

    Changes in Best Corrected Visual Acuity (BCVA), Snellen and/or LogMar.

    Measured: 6 months

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

    Reported blurred vision, conjunctival hyperemia, dryness, itching, irritation, pain, light sensitivity, eye lash growth, changes in iris colour, orbital fat atrophy/periorbitopathy, intraocular inflammation, macular oedema, vitreous floaters.

    Measured: 6 months

  3. Adherence to Study Treatment

    Evaluation of number and percentage of participants adherence/compliance to study treatment (Yes or No).

    Measured: 6 months

  4. Additional Glaucoma Interventions

    Evaluation of number and percentage of occurrence of additional glaucoma-related procedures during the follow-up period [Laser trabeculoplasty and/or cataract surgery].

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study startMay 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07074782
Sponsor's protocol ID
ECR-GLC-2025-18
Acronym
NEUROPA
Status last verified
Dec 2025
First submitted
1 Jul 2025
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jonas JB, Aung T, Bourne RR, Bron AM, Ritch R, Panda-Jonas S. Glaucoma. Lancet. 2017 Nov 11;390(10108):2183-2193. doi: 10.1016/S0140-6736(17)31469-1. Epub 2017 May 31.

    PubMed 28577860
  • Leske MC, Heijl A, Hyman L, Bengtsson B, Dong L, Yang Z; EMGT Group. Predictors of long-term progression in the early manifest glaucoma trial. Ophthalmology. 2007 Nov;114(11):1965-72. doi: 10.1016/j.ophtha.2007.03.016. Epub 2007 Jul 12.

    PubMed 17628686
  • Peters D, Bengtsson B, Heijl A. Lifetime risk of blindness in open-angle glaucoma. Am J Ophthalmol. 2013 Oct;156(4):724-30. doi: 10.1016/j.ajo.2013.05.027. Epub 2013 Aug 7.

    PubMed 23932216
  • Chang EE, Goldberg JL. Glaucoma 2.0: neuroprotection, neuroregeneration, neuroenhancement. Ophthalmology. 2012 May;119(5):979-86. doi: 10.1016/j.ophtha.2011.11.003. Epub 2012 Feb 18.

    PubMed 22349567
  • Lee HP, Tsung TH, Tsai YC, Chen YH, Lu DW. Glaucoma: Current and New Therapeutic Approaches. Biomedicines. 2024 Sep 3;12(9):2000. doi: 10.3390/biomedicines12092000.

    PubMed 39335514
  • Yamamoto K, Sato K, Yukita M, Yasuda M, Omodaka K, Ryu M, Fujita K, Nishiguchi KM, Machida S, Nakazawa T. The neuroprotective effect of latanoprost acts via klotho-mediated suppression of calpain activation after optic nerve transection. J Neurochem. 2017 Feb;140(3):495-508. doi: 10.1111/jnc.13902. Epub 2016 Dec 27.

    PubMed 27859240
  • Yamagishi R, Aihara M, Araie M. Neuroprotective effects of prostaglandin analogues on retinal ganglion cell death independent of intraocular pressure reduction. Exp Eye Res. 2011 Sep;93(3):265-70. doi: 10.1016/j.exer.2011.06.022. Epub 2011 Jul 26.

    PubMed 21791206
  • Kanamori A, Naka M, Fukuda M, Nakamura M, Negi A. Latanoprost protects rat retinal ganglion cells from apoptosis in vitro and in vivo. Exp Eye Res. 2009 Mar;88(3):535-41. doi: 10.1016/j.exer.2008.11.012. Epub 2008 Dec 3.

    PubMed 19084521
  • Nakanishi Y, Nakamura M, Mukuno H, Kanamori A, Seigel GM, Negi A. Latanoprost rescues retinal neuro-glial cells from apoptosis by inhibiting caspase-3, which is mediated by p44/p42 mitogen-activated protein kinase. Exp Eye Res. 2006 Nov;83(5):1108-17. doi: 10.1016/j.exer.2006.05.018. Epub 2006 Jul 12.

    PubMed 16839545
  • Kudo H, Nakazawa T, Shimura M, Takahashi H, Fuse N, Kashiwagi K, Tamai M. Neuroprotective effect of latanoprost on rat retinal ganglion cells. Graefes Arch Clin Exp Ophthalmol. 2006 Aug;244(8):1003-9. doi: 10.1007/s00417-005-0215-0. Epub 2006 Jan 13.

    PubMed 16411104
  • Drago F, Valzelli S, Emmi I, Marino A, Scalia CC, Marino V. Latanoprost exerts neuroprotective activity in vitro and in vivo. Exp Eye Res. 2001 Apr;72(4):479-86. doi: 10.1006/exer.2000.0975.

    PubMed 11273675
  • 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.

    PubMed 32985274
  • Wagner IV, Stewart MW, Dorairaj SK. Updates on the Diagnosis and Management of Glaucoma. Mayo Clin Proc Innov Qual Outcomes. 2022 Nov 16;6(6):618-635. doi: 10.1016/j.mayocpiqo.2022.09.007. eCollection 2022 Dec.

    PubMed 36405987
  • Hill D, Choi S, Cordeiro MF. In Vivo Detection of Retinal Ganglion Cell Stress in Rodents with DARC. Methods Mol Biol. 2023;2708:123-129. doi: 10.1007/978-1-0716-3409-7_13.

    PubMed 37558966
  • Cordeiro MF, Hill D, Patel R, Corazza P, Maddison J, Younis S. Detecting retinal cell stress and apoptosis with DARC: Progression from lab to clinic. Prog Retin Eye Res. 2022 Jan;86:100976. doi: 10.1016/j.preteyeres.2021.100976. Epub 2021 Jun 5.

    PubMed 34102318

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Association for Innovation and Biomedical Research on Light and Image at 10 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, Germany, Italy, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ana S Silva, PhD (+351239480112, neuropa@aibili.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07074782, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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