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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Omikron Italia S.r.l.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

8 Nov 2023 → ongoing

Decision date (initial)

2023-07-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Omikron Italia

External identifiers

EU CT number

2022-502273-42-00

ClinicalTrials.gov

NCT05710198

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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.

Secondary objectives 1

1. Evaluation of the effect of citicoline eye drops 2% on changes in structural parameters and the confirmation of the safety profile of citicoline eye drops 2%

Conditions and MedDRA coding

Glaucoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. rate of change in MD in the study eye, an index of the global deviation of the age-corrected normal values. The objective is to assess the difference in the rate of progression over 3 years of study in the experimental arm compared to the control arm

Secondary endpoints 1

1. To establish differences in the rate of change of structural thickness (peripapillary Retinal Nerve Fibre Layer (RNFL) with Optical Coherence Tomography – OCT) and macular thickness of the inner retina (RNFL, Ganglion Cell Layer and Ganglion Cell + Inner Plexiform Layer complex evaluated by SD-OCT)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Omikron Italia S.r.l.

Sponsor organisation

Omikron Italia S.r.l.

Address

Viale Bruno Buozzi 5

City

Rome

Postcode

00197

Country

Italy

Scientific contact point

Organisation

Omikron Italia S.r.l.

Contact name

Rebecca Rascio

Public contact point

Organisation

Omikron Italia S.r.l.

Contact name

Rebecca Rascio

Third parties 2

Locations

7 EU/EEA countries · 35 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 86 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications