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

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

Sponsors

Lead Sponsor: Fondazione G.B. Bietti, IRCCS

Source 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.

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.

Overall Status Completed
Start Date September 23, 2015
Completion Date June 7, 2019
Primary Completion Date October 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes of Retinal sensitivity and contrast sensitivity function after topical citicoline use in patients with diabetic retinopathy Functional retinal changes at 36 months
Secondary Outcome
Measure Time Frame
Morphological retinal changes after topical citicoline use in patients with diabetic retinopathy Morphological retinal changes at 36 months
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: OMK2 group

Description: topical administration of OMk2 ophthalmic solution for 36 months three times/day

Arm Group Label: OMK2 group

Intervention Type: Other

Intervention Name: Placebo group

Description: topical administration of ophthalmic placebo solution for 36 months three times/day

Arm Group Label: Placebo group

Eligibility

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Location
Facility: Fondazione G.B.Bietti
Location Countries

Italy

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Fondazione G.B. Bietti, IRCCS

Investigator Full Name: Mariacristina Parravano

Investigator Title: Head of Retina Unit

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: OMK2 group

Type: Experimental

Description: Patients receiving topical administration of OMk2 ophthalmic solution for 36 months three times/day

Label: Placebo group

Type: Placebo Comparator

Description: Patients receiving receiving only the excipients of OMk2 (placebo) for 36 months three times/day

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Prospective, interventional, randomized, double-masked, monocentric pilot study

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov