Status:
ACTIVE_NOT_RECRUITING
Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
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 / exclusi...
Detailed Description
Sixty patients affected by bilateral open angle glaucoma, between the ages of 20 and 70, will be enrolled in the study within a maximum time frame of 12 months. The enrollment will be performed at T0 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
- Cataract or maculopathy
- Argon laser trabeculoplasty (ALT) within the previous 6 months
- 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
- 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
- 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)
- Pregnancy, breastfeeding
- Diabetes
- Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
- Concomitant use of anticoagulants and lithium
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05315206
Start Date
January 25 2022
End Date
July 1 2025
Last Update
February 26 2025
Active Locations (2)
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1
Fondazione BIetti, Britannico Hospital
Roma, Italy, 00184
2
Fondazione G.B. Bietti-IRCCS
Rome, Italy, 00199