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
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, interventional, randomized, double-masked, monocentric pilot study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009980
|Roma, Italy, 00135|