Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy

University of Guadalajara

Status and phase: Completed; Phase 2

Conditions: Non-proliferative Diabetic Retinopathy; Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: Ubiquinone; Drug: Combined antioxidant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02062034

RDNP-20100102

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.

Full description

The investigators are interested in demonstrating the efficacy of Ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.

Enrollment: 61 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes mellitus
• Patients with non proliferative diabetic retinopathy
• Glycated hemoglobin < 12.0%
• Signing of informed consent

Exclusion criteria

• Patients with clinically significant macular edema
• Patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy)
• Pretreatment with argon laser or excimer laser Ophthalmology surgery
• Any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration)
• Pregnancy, lactation, inadequate use of contraception
• Antioxidant drug and/or supplements six months previous to enrollment
• Renal and/or hepatic failure
• Age under 30 or over 75 years
• Severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy)
• Blood dyscrasias
• Have or have had cancer or other serious illness
• Neurodegenerative process
• Allergy to vitamins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 3 patient groups, including a placebo group

Ubiquinone

Experimental group

Description:

400mg daily of oral ubiquinone for 24 weeks

Treatment:

Drug: Ubiquinone

Combined antioxidant therapy

Experimental group

Description:

(1mg copper + 20mg zinc + 180mg vitamin C + 30mg vitamin E + 1mg zeaxanthin + 4mg astaxanthin + 10mg lutein) daily of oral antioxidant combined therapy for 24 weeks

Treatment:

Drug: Combined antioxidant therapy

Placebo

Placebo Comparator group

Description:

Placebo. 100mg daily oral intake for 24 weeks

Treatment:

Drug: Placebo