Status:
COMPLETED
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 sugge...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04009980
Start Date
September 23 2015
End Date
June 7 2019
Last Update
July 8 2019
Active Locations (1)
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1
Fondazione G.B.Bietti
Roma, Italy, 00135