Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04009980
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS

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.


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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009980


Locations
Layout table for location information
Italy
Fondazione G.B.Bietti
Roma, Italy, 00135
Sponsors and Collaborators
Fondazione G.B. Bietti, IRCCS

Publications:

Layout table for additonal information
Responsible Party: Mariacristina Parravano, Head of Retina Unit, Fondazione G.B. Bietti, IRCCS
ClinicalTrials.gov Identifier: NCT04009980     History of Changes
Other Study ID Numbers: RET04/2015
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariacristina Parravano, Fondazione G.B. Bietti, IRCCS:
citicoline
neuropathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Cytidine Diphosphate Choline
Nootropic Agents