Open-angle GlaucomaPhase 1NCT02984813
Safety and Efficacy of Anti-Oxidants and Anti-inflammatory Agents in Glaucoma and Diabetic Retinopathy
A Phase 1 study testing GlaucoHealth and GlaucoSelect in people with Open-angle Glaucoma and Diabetic Retinopathy, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Diabetic Retinopathy
- What is being tested?
- GlaucoHealth and GlaucoSelect
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2016to 15 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
About this study
Official title: Measurement of Oxidative Stress of Retinal Ganglion Cells With and Without Anti-oxidants and Anti-inflammatory Agents in Patients With Glaucoma and Diabetic Retinopathy as Determined by Mitochondrial Flavoprotein Fluorescence
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.
Read the detailed description
This investigation is using over the counter supplements. The investigation is intended only to evaluate their effect on the structure or function of mitochondria as it relates to the autofluorescence imaging being conducted in the study. They are not being studied to evaluate their ability to diagnose, cure, mitigate, or treat disease.
These ingredients in these combinations of nutritional supplements have also been reported beneficial in diabetic retinopathy. Patients with diabetic retinopathy will be added later as an additional arm and an amendment to this effect will be submitted when that portion of the study is ready to be initiated. That amendment will include background material, appropriate inclusion and exclusion criteria, informed consent, and references. At the current time, only the glaucoma proposal and glaucoma patients will be enrolled according to this submitted protocol.
- Conditions
- Open-angle Glaucoma, Diabetic Retinopathy
- Being tested
- GlaucoHealth, GlaucoSelect, Placebo
- Medical subject headings
- Glaucoma, Open-Angle, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlaucoHealthDrug
Containing alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract
GlaucoSelectDrug
Containing curcumin, bilberry extract, and grape seed extract
PlaceboDrug
No active ingredients
| Study group | Role | What they receive |
|---|---|---|
| GlaucoHealth | Experimental | 2 pills once daily in the morning for 3 months Receives: Drug: GlaucoHealth |
| GlaucoSelect | Experimental | 2 pills once daily in the morning for 3 months Receives: Drug: GlaucoSelect |
| Placebo | Placebo comparator | 2 pills once daily in the morning for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flavoprotein fluorescence index
Average Intensity and Average Curve Width
Measured: 3 months
Secondary outcomes (2)
Visual acuity
Measured: 3 months
Humphrey visual field testing (24-2)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start15 Apr 2016
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Ritch, MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984813
- Sponsor's protocol ID
- 15.25
- Status last verified
- Mar 2021
- First submitted
- 3 Dec 2016
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Oxidative Stress of Retinal Ganglion Cells With and Without Anti-oxidants and Anti-inflammatory Agents in Patients With Glaucoma and Diabetic Retinopathy as Determined by Mitochondrial Flavoprotein Fluorescence
- ClinicalTrials.gov ID
- NCT02984813
- Acronym / sponsor ID
- 15.25
- Conditions
- Open-angle Glaucoma, Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left the institution
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This investigation is using over the counter supplements. The investigation is intended only to evaluate their effect on the structure or function of mitochondria as it relates to the autofluorescence imaging being conducted in the study. They are not being studied to evaluate their ability to diagnose, cure, mitigate, or treat disease.
These ingredients in these combinations of nutritional supplements have also been reported beneficial in diabetic retinopathy. Patients with diabetic retinopathy will be added later as an additional arm and an amendment to this effect will be submitted when that portion of the study is ready to be initiated. That amendment will include background material, appropriate inclusion and exclusion criteria, informed consent, and references. At the current time, only the glaucoma proposal and glaucoma patients will be enrolled according to this submitted protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GlaucoHealth | Experimental | Drug: GlaucoHealth2 pills once daily in the morning for 3 months |
| GlaucoSelect | Experimental | Drug: GlaucoSelect2 pills once daily in the morning for 3 months |
| Placebo | Placebo comparator | Drug: Placebo2 pills once daily in the morning for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Both eyes will be enrolled.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlaucoHealthContaining alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract | Drug | GlaucoHealth |
| GlaucoSelectContaining curcumin, bilberry extract, and grape seed extract | Drug | GlaucoSelect |
| PlaceboNo active ingredients | Drug | Placebo |
Primary outcome
Flavoprotein fluorescence index
Time frame: 3 months
Average Intensity and Average Curve Width
2 secondary outcomes
Visual acuity
Time frame: 3 months
Humphrey visual field testing (24-2)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Ritch, MD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GlaucoHealth and GlaucoSelect in people with Open-angle Glaucoma and Diabetic Retinopathy, run by The New York Eye & Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flavoprotein fluorescence index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.