NCT05315206Fut, nem toboroz
Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution
Modulation of Neuronal Connettivity Along the Visual Pathways in Patients Affected by Glaucoma Throug Treatment With Citicoline Oral Solution: Multimodal Morpho-funcional Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. febr. 26.
Rövid összefoglaló (regiszter, angolul)
A prospective, multicentre, randomized, blinded, masked study that involves the enrollment of 60 patients affected by open angle glaucoma (OAG). Patients selected according to the inclusion / exclusion criteria, after signing the informed consent, will be randomized into two groups: 1. In a group of patients with OAG, Citicoline in oral solution (10 ml / day, Neurotidine®) will be administered for 12 months (Citicoline Treated Group, TC Group) 2. in another group of patients with OAG will be administered Placebo (Containing all excipients of Neurotidine ®) (10 ml / day) for 12 months (Placebo Treated Group, TP Group) Randomization will be done by dividing the selected patients into two groups based on similar characteristics of: age, perimetric defect and, mainly, retinal-cortical time (RCT) values. Patients will be assigned to each group by an investigator not involved in functional and structural testing. The key will be opened only at the end of the treatment in order to evaluate the first effects. The Primary Objective was to evaluate whether treatment with Citicoline in oral solution can produce an improvement of the post-retinal neural conduction, that is delayed in patients with OAG. The Secondary objective was to evaluate in patients with OAG whether the possible changes in post-retinal neural conduction induced by treatment with Citicoline in oral solution (information obtained through electrophysiological recordings) are associated or not with morphological and functional variations of the nervous structures forming the visual pathways (nucleus geniculatus lateral, optic tract, visual cortex, information obtained through the acquisition of structural and functional magnetic resonance imaging) and whether both conditions can be related to the morpho-functional variations of the retinal ganglion cells and of the visual field (VF).
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 29 (tényleges)
- Első benyújtás
- 2022. febr. 4.
- Kezdés
- 2022. jan. 25.
- Elsődleges befejezés
- 2023. dec. 31.
- Fő szponzor
- Fondazione G.B. Bietti, IRCCS
- Betegségek
- Zöldhályog (glaukóma)
- NCT-szám
- NCT05315206
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 29
- 2022. jan. 25. és az elsődleges befejezés (2023. dec. 31.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin, retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and / or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine, Citicoline and / or its derivatives must have been suspended at least 6 months prior to inclusion in the study)
- Concomitant use of anticoagulants and lithium
Más betegség
- Known hypersensitivity to the study product
- Secondary causes of ocular hypertension, including systemic or topical use of steroids
- Positive history of ocular or systemic diseases that could preclude enrollment in the study in the opinion of the investigators
- Diabetes
Laborértékek
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- Changes in systemic therapies that could compromise intraocular pressure values (beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the 30 days prior to enrollment
Egyéb
- Cataract or maculopathy
- Pregnancy, breastfeeding
- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
Kiket keres a vizsgálat
- Age between 20 and 70 years old
- Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey 24-2 standard SITA with mean deviation between -6 and -25 dB) and glaucomatous appearance of the optic nerve
- Visual acuity not less than 5/10
- Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase inhibitors. Such drugs can be used both alone and in combination with each other.
- Documented post-retinal nerve conduction delay through simultaneous recording of VEP and PERG showing an increase in RCT
Életkor a regiszterben: 20 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fondazione BIetti, Britannico Hospital | Roma | Olaszország | Ismeretlen állapot |
| Fondazione G.B. Bietti-IRCCS | Rome | Olaszország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.