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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-23

Study Completion Date

2019-06-07

Brief Summary

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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.

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Detailed Description

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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

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, interventional, randomized, double-masked, monocentric pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OMK2 group

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

Group Type EXPERIMENTAL

OMK2 group

Intervention Type OTHER

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

topical administration of ophthalmic placebo solution for 36 months three times/day

Interventions

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OMK2 group

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

Intervention Type OTHER

Placebo group

topical administration of ophthalmic placebo solution for 36 months three times/day

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No