Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Open-angle Glaucoma, Diabetic Retinopathy

In brief

This study is a multi-armed protocol designed to evaluate the safety and efficacy of two different combinations of nutritional supplements (study drug) (Glauco-Health and Glauco-Select) chosen for their potential to protect retinal ganglion cells against oxidative stress, low-grade inflammation, and mitochondrial dysfunction in patients with open-angle glaucoma and diabetic retinopathy. Oxidative stress and retinal cellular dysfunction will be measured using a Retinal Metabolic Analyzer (RMA) in this randomized, single center, double masked study. Patients with glaucoma will be divided into three treatment arms randomized to receive either Glauco-Health, Glauco-Select, or placebo.

Key facts

Study ID

NCT02984813

Run by

The New York Eye & Ear Infirmary

People needed

21

Starts

2016-04-15

Expected to finish

2017-01-15

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female of any race, at least 18 years of age.
• Has provided verbal and written informed consent.
• Able and willing to follow instructions, including participation in all study assessments and visits.
• Eyes with moderate to severe primary open-angle glaucoma will be enrolled. Glaucoma severity will be graded using the WHO glaucoma staging system.
• OAG eyes are defined by clinical findings consistent with glaucomatous optic neuropathy (Ex: thinning, excavation, rim erosion or notching of the neuroretinal rim)
• Reproducible visual field defects on at least three examinations as measured by a glaucoma hemifield test (GHT) result outside normal limits and/or the presence of at least three consecutive test points on the pattern deviation plot with P<1% and at least one at P<0.05%, not including points on the edge of the field.
• Both eyes will be enrolled.
• Refractive error ≤5 diopters and astigmatism ≤3 diopters

You may not qualify if…

• Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assignment, such as age-related macular degeneration, macular dystrophy, retinopathy from systemic diseases, marked ocular media opacities that obscure retinal imaging, etc.
• BCVA <20/200
• Concurrent conjunctivitis, keratitis or uveitis
• History of penetrating ocular trauma.
• Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or anterior chamber.
• Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
• A woman who is pregnant, nursing an infant, or planning a pregnancy
• Has a known adverse reaction and/or sensitivity to the study drug or its compound.
• a. Including: alpha lipoic acid, citicoline, Co-enzyme Q-10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, green tea extract, and bilberry extract.
• Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to Visit 1.
• Is planning on having surgery at any time throughout the study duration (90 days from initiation)
• Is currently receiving chemotherapy
• Has a history of diabetes mellitus, seizure(s), bleeding disorder(s)
• Has a history of uncontrolled hypertension (≥180 systolic or ≥110 diastolic on two successive measures)
• Has a history of any radiation around the eyes
• Currently using anticoagulant/antiplatelet drugs (patients on coumadin, clopidogral (Plavix), and plasugrel (Effient) will be excluded but that patients taking aspirin will be allowed)
• Unwilling or unable to cease using other anti-oxidative agents or drugs.
• Dilated pupil diameter less than 5 millimeters
• Fluorescein drop administration within 8 hours before imaging
• History of cataract surgery in the 3 months prior to imaging
• History of any other intraocular surgery within 4 months prior to enrollment
• Corticosteroid or immunosuppressive therapy within 6-months prior to imaging
• Lens opacity ≥grade 3 on ARLNS on standard photographs (Appendix 6)
• History of vitrectomy
• Monocular patients

Where it is running

• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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