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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Other: OMK2 group
* Other: Placebo group


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, interventional, randomized, double-masked, monocentric pilot study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMK2 group<br>Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day | Other: OMK2 group<br>* topical administration of OMk2 ophthalmic solution for 36 months three times/day<br>|
| Placebo Comparator: Placebo group<br>Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day | Other: Placebo group<br>* topical administration of ophthalmic placebo solution for 36 months three times/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy | To evaluate functional retinal parameters : retinal sensitivity by Humphrey Matrix and contrast sensitivity function by Pelli Robson in patients with diabetic retinopathy | Functional retinal changes at 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy | To evaluate morphological retinal parameters by Spectral Domain OCT( SD-OCT ) and by Adaptive Optics (AO) at each time point of follow up : retinal thickness, RNFL thickness, inner retinal thickness and outer retinal thickness. | Morphological retinal changes at 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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citicoline, neuropathy