ClinicalTrials.Veeva

Menu

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

U

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems