Diabetic Retinopathy Clinical Trial
Official title:
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
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.
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.
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