NCT04009980

Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.

Long-term Morphological and Functional Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus: Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fondazione G.B. Bietti, IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Citicoline (cytidine-5'-diphosphocholine) is an essential precursor in the synthesis of phosphatidylcholine, a component of cell membranes. Several experimental in vitro and in vivo studies have suggested that citicoline plays a neuroprotective role. A recent clinical study has shown that treatment with topical citicoline induces, after 60 days of therapy, a significant improvement in the ganglion cell function .In addition topical citicoline has been demonstrated in vivo a neuroprotective effect in preventing diabetic retinopathy . The Investigators want to evaluate if citicoline may reduce the progression of retinal damage in patients with mild diabetic retinopathy.

Detailed description

The investigators evaluated patients with mild signs of diabetic retinopathy (DR) treated with eye-drop solution with citicoline ( OMk2 ophthalmic solution). All patients was randomized in two groups (10:10), one receiving topical administration of OMk2 ophthalmic solution for 36 months and one group receiving only the excipients of OMk2 (placebo). Omk2 ophthalmic solution and the placebo will be used for 36 months three times/day. They will undergo a complete ocular examination at baseline and at 6-, 12-, 18-, 24-, 30- and 36- months after treatment.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
OTHER	OMK2 group	topical administration of OMk2 ophthalmic solution for 36 months three times/day
OTHER	Placebo group	topical administration of ophthalmic placebo solution for 36 months three times/day

Timeline

• Start date: 2015-09-23
• Primary completion: 2018-10-01
• Completion: 2019-06-07
• First posted: 2019-07-08
• Last updated: 2019-07-08

Locations

1 site across 1 country: Italy