Authorised Therapeutic confirmatory (Phase III) Glaucoma

A study to assess efficacy of citicoline on visual field preservation in patients with glaucoma

EU CTIS ID: 2022-502273-42-00

What this study is testing

Determining whether citicoline eye drops 2% are superior to placebo in reducing VF deterioration in patients with progressing open angle glaucoma (OAG) treated according to best clinical practice.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1.Signed written informed consent. 2.Age ≥ 18 years. 3.Eyes with OAG, Pseudoexfoliation and pigmentary glaucoma will be included. 4.Best Corrected Visual Acuity (BCVA) ≥ 0.5 for the study eye. 5.Controlled IOP (≤ 18 mmHg, average of the last 3 measurements in the clinic) in the study eye. 6.Visual field MD not worse than -12 dB at the latest assessment in the clinic for the study eye. 7.Glaucoma definition will be based on VF damage (24-2, any SITA strategy) and spatially congruent glaucomatous changes at the ONH. If both eyes are eligible, the eye with the better MD will be chosen as the study eye. Please refer to the following definitions: • OAG: a reproducible glaucomatous VF defect in at least one eye in reliable VFs (false positive rate ≤15%) with corresponding glaucomatous damage to the Optic Nerve Head (ONH), with an open angle on gonioscopy and in the absence of a retinal, neurological or adnexal condition that could account for the VF loss. • Glaucomatous damage to the Optic Nerve Head: focal or diffuse loss of neuro-retinal tissue identified by the investigator by means of ophthalmoscopy AND/OR fundus photographs AND/OR Optical Coherence Tomography imaging. • Reproducible glaucomatous VF defect: a Glaucoma Hemifield Test (GHT) outside normal limits AND a cluster of 3 or more locations, 2 of which are depressed on the pattern deviation plot at a P value of <5% and 1 of which is depressed at a P value of <1%, on at least 2 consecutive reliable fields. At least 1 common location in the cluster should be depressed at <5% in the 2 consecutive VFs. • Definition of a VF cluster: each depressed location in the clusters should be adjacent to at least one other depressed location. 8.Women of childbearing potential (WOCBP) willing to use a highly effective method of contraception for up to 90 days after the last dose of treatment.

You likely can't join if

  • 1. Cataract in the study eye which, in the opinion of the clinician, may require cataract surgery within the next three years. 2. Only-eye patients (visual acuity < 0.1 decimals in one eye or more than two paracentral VF locations with a sensitivity of < 10 dB). 3. Known intolerance or allergy to any of the components in the eye drops. 4. Diode laser treatment or glaucoma surgery in the past 2 years or cataract surgery within the last 6 months in the study eye. 5. Eyes with any type of glaucoma other than primary, pseudoexfoliative or pigmentary OAG. 6. Patients with other ocular or systemic comorbidities that, in the opinion of the Investigator, might affect the VF or the execution of the test. 7. Patients already on topical or systemic citicoline treatment. 8. Patients taking other systemic or topical potential neuroprotectors used in glaucoma, i.e., citicoline (CDP-choline), choline and derivatives, coenzyme Q10, vitamin B3 / niacin/ nicotinamide/ nicotinamide riboside chloride /nicotinic acid, ginkgo biloba, and unwilling to suspend these treatments and undergo a washout period of 6 months prior to the study 9. Patients unable to perform reliable VF tests, based on the assessment of the last 4 available 24-2 Humphrey Field Analyzer (HFA) VF tests performed in the clinic with a false positive rate (FP) ≤ 15%. 10. Although effects on the human fetus are considered unlikely, these effects are still unknow and the safety of citicoline for use during pregnancy has not been established. Therefore, pregnant and nursing women will be excluded from the study.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.