Diabetic Retinopathy
Conditions
Keywords
citicoline, neuropathy
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.
Interventions
OTHEROMK2 group
topical administration of OMk2 ophthalmic solution for 36 months three times/day
OTHERPlacebo group
topical administration of ophthalmic placebo solution for 36 months three times/day
Sponsors
Fondazione G.B. Bietti, IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Prospective, interventional, randomized, double-masked, monocentric pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy | 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
| Measure | Time frame | Description |
|---|---|---|
| Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy | 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. |
Countries
Italy
Outcome results
None listed