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

NCT02984813 | Terminated Phase 1 DMC

• 1 other identifier: 15.25
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Open-angle Glaucoma; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Flavoprotein fluorescence index

  Average Intensity and Average Curve Width

  3 months

Secondary Outcomes (2)

• Visual acuity

  3 months

• Humphrey visual field testing (24-2)

  3 months

Study Arms (3)

GlaucoHealth

EXPERIMENTAL

2 pills once daily in the morning for 3 months

Drug: GlaucoHealth

GlaucoSelect

EXPERIMENTAL

2 pills once daily in the morning for 3 months

Drug: GlaucoSelect

Placebo

PLACEBO COMPARATOR

2 pills once daily in the morning for 3 months

Drug: Placebo

Interventions

GlaucoHealth DRUG

Containing alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract

GlaucoHealth

GlaucoSelect DRUG

Containing curcumin, bilberry extract, and grape seed extract

GlaucoSelect

Placebo DRUG

No active ingredients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Robert Ritch, MD

  Shelley and Steven Einhorn Distinguished Chair Professor of Ophthalmology Surgeon Director Emeritus and Chief, Glaucoma Services The New York Eye and Ear Infirmary of Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: April 15, 2016
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2017
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)