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

Fondazione G.B. Bietti, IRCCS

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Other: Placebo group; Other: OMK2 group

Study type: Interventional

Funder types: Other

Identifiers

NCT04009980

RET04/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 1 DM
• Diagnosis of mild Diabetic rethnopathy (DR)
• Retinal sensitivity impairment evaluated by means of frequency doubling technology (Matrix FDT) with a mean deviation (MD) p value <5% or with two locations with p <5% and one location with p<1% in the total or pattern deviation plots.

Exclusion criteria

• Hyperopia higher than +5 diopter (D)
• myopia higher than -8 D
• astigmatism higher than 2 D
• Visual acuity below 20/25
• significant media opacity
• previous ocular surgery
• previous diagnosis of glaucoma
• uveitis
• retinal disease other than mild diabetic retinopathy
• patients with any ocular disease
• systemic disease other than diabetes
• Any signs of diabetic retinopathy more advanced than mild as coded by ICDRSS (e.g. macular edema or any sign of proliferative DR)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

OMK2 group

Experimental group

Description:

Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day

Treatment:

Other: OMK2 group

Placebo group

Placebo Comparator group

Description:

Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day

Treatment:

Other: Placebo group