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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OMK2 group
Placebo group
Sponsored by
Fondazione G.B. Bietti, IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring citicoline, neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Fondazione G.B.Bietti

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OMK2 group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 6, 2019
Last Updated
July 2, 2019
Sponsor
Fondazione G.B. Bietti, IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT04009980
Brief Title
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 23, 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
June 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione G.B. Bietti, IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
citicoline, neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, interventional, randomized, double-masked, monocentric pilot study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMK2 group
Arm Type
Experimental
Arm Description
Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day
Intervention Type
Other
Intervention Name(s)
OMK2 group
Intervention Description
topical administration of OMk2 ophthalmic solution for 36 months three times/day
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
topical administration of ophthalmic placebo solution for 36 months three times/day
Primary Outcome Measure Information:
Title
Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy
Description
To evaluate functional retinal parameters : retinal sensitivity by Humphrey Matrix and contrast sensitivity function by Pelli Robson in patients with diabetic retinopathy
Time Frame
Functional retinal changes at 36 months
Secondary Outcome Measure Information:
Title
Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy
Description
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.
Time Frame
Morphological retinal changes at 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Fondazione G.B.Bietti
City
Roma
ZIP/Postal Code
00135
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20130282
Citation
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.
Results Reference
background
PubMed Identifier
23841106
Citation
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.
Results Reference
background
PubMed Identifier
22581817
Citation
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. Erratum In: Stroke. 2012 Nov;43(11):e169.
Results Reference
background
PubMed Identifier
18929133
Citation
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.
Results Reference
background
PubMed Identifier
10366081
Citation
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.
Results Reference
background
PubMed Identifier
24881599
Citation
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.
Results Reference
background
PubMed Identifier
32180131
Citation
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.
Results Reference
derived

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

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