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NCT Number: NCT04009980

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

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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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione G.B.Bietti

Roma, 00135, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OMK2 group

Other

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

Placebo Group

Other

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

Primary outcomes

  1. Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy

    Time frame: Functional retinal changes at 36 months

    To evaluate functional retinal parameters : retinal sensitivity by Humphrey Matrix and contrast sensitivity function by Pelli Robson in patients with diabetic retinopathy

Secondary outcomes

  1. Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy

    Time frame: Morphological retinal changes at 36 months

    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.

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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