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出境医 / 临床实验 / Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.

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

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.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Other: OMK2 group Other: Placebo group Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, interventional, randomized, double-masked, monocentric pilot study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 23, 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : June 7, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: OMK2 group
Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day
 Other: OMK2 group
topical administration of OMk2 ophthalmic solution for 36 months three times/day
Placebo Comparator: Placebo group
Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day
 Other: Placebo group
topical administration of ophthalmic placebo solution for 36 months three times/day
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
Layout table for location information
Italy
Fondazione G.B.Bietti
Roma, Italy, 00135
Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE September 23, 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, interventional, randomized, double-masked, monocentric pilot study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • Other: OMK2 group
    topical administration of OMk2 ophthalmic solution for 36 months three times/day
  • Other: Placebo group
    topical administration of ophthalmic placebo solution for 36 months three times/day
Study Arms  ICMJE
  • Experimental: OMK2 group
    Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day
    Intervention: Other: OMK2 group
  • Placebo Comparator: Placebo group
    Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day
    Intervention: Other: Placebo group
Publications *
  • van Dijk HW, Verbraak FD, Kok PH, Garvin MK, Sonka M, Lee K, Devries JH, Michels RP, van Velthoven ME, Schlingemann RO, Abràmoff 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.
  • Vujosevic S, Midena E. Retinal layers changes in human preclinical and early clinical diabetic retinopathy support early retinal neuronal and Müller cells alterations. J Diabetes Res. 2013;2013:905058. doi: 10.1155/2013/905058. Epub 2013 Jun 12.
  • Diederich K, Frauenknecht K, Minnerup J, Schneider BK, Schmidt A, Altach E, Eggert V, Sommer CJ, Schäbitz 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.
  • 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.
  • 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.
  • 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.
  • Parravano M, Scarinci F, Parisi V, Giorno P, Giannini D, Oddone F, Varano M. Citicoline and Vitamin B(12) 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019) 		20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 7, 2019
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009980
Other Study ID Numbers  ICMJE RET04/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS
Study Sponsor  ICMJE Fondazione G.B. Bietti, IRCCS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fondazione G.B. Bietti, IRCCS
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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