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

NCT04009980 | Completed DMC

• 1 other identifier: RET04/2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy

Keywords

citicoline; neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Morphological retinal changes at 36 months

Study Arms (2)

OMK2 group

EXPERIMENTAL

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

Other: OMK2 group

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo group

Interventions

OMK2 group OTHER

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

OMK2 group

Placebo group OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

Fondazione G.B.Bietti

Roma, 00135, Italy

Location

Related Publications (7)

• van Dijk HW, Verbraak FD, Kok PH, Garvin MK, Sonka M, Lee K, Devries JH, Michels RP, van Velthoven ME, Schlingemann RO, Abramoff MD. Decreased retinal ganglion cell layer thickness in patients with type 1 diabetes. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3660-5. doi: 10.1167/iovs.09-5041. Epub 2010 Feb 3.

  PMID: 20130282 BACKGROUND

• Vujosevic S, Midena E. Retinal layers changes in human preclinical and early clinical diabetic retinopathy support early retinal neuronal and Muller cells alterations. J Diabetes Res. 2013;2013:905058. doi: 10.1155/2013/905058. Epub 2013 Jun 12.

  PMID: 23841106 BACKGROUND

• Diederich K, Frauenknecht K, Minnerup J, Schneider BK, Schmidt A, Altach E, Eggert V, Sommer CJ, Schabitz WR. Citicoline enhances neuroregenerative processes after experimental stroke in rats. Stroke. 2012 Jul;43(7):1931-40. doi: 10.1161/STROKEAHA.112.654806. Epub 2012 May 10.

  PMID: 22581817 BACKGROUND

• Parisi V, Coppola G, Centofanti M, Oddone F, Angrisani AM, Ziccardi L, Ricci B, Quaranta L, Manni G. Evidence of the neuroprotective role of citicoline in glaucoma patients. Prog Brain Res. 2008;173:541-54. doi: 10.1016/S0079-6123(08)01137-0.

  PMID: 18929133 BACKGROUND

• Parisi V, Manni G, Colacino G, Bucci MG. Cytidine-5'-diphosphocholine (citicoline) improves retinal and cortical responses in patients with glaucoma. Ophthalmology. 1999 Jun;106(6):1126-34. doi: 10.1016/S0161-6420(99)90269-5.

  PMID: 10366081 BACKGROUND

• Roberti G, Tanga L, Parisi V, Sampalmieri M, Centofanti M, Manni G. A preliminary study of the neuroprotective role of citicoline eye drops in glaucomatous optic neuropathy. Indian J Ophthalmol. 2014 May;62(5):549-53. doi: 10.4103/0301-4738.133484.

  PMID: 24881599 BACKGROUND

• Parravano M, Scarinci F, Parisi V, Giorno P, Giannini D, Oddone F, Varano M. Citicoline and Vitamin B12 Eye Drops in Type 1 Diabetes: Results of a 3-year Pilot Study Evaluating Morpho-Functional Retinal Changes. Adv Ther. 2020 Apr;37(4):1646-1663. doi: 10.1007/s12325-020-01284-3. Epub 2020 Mar 16.

  PMID: 32180131 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Retina Unit

Model Details: Prospective, interventional, randomized, double-masked, monocentric pilot study

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: July 8, 2019
• Study Start: September 23, 2015
• Primary Completion: October 1, 2018
• Study Completion: June 7, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)