Glaucomatous NeuropathyPhase 1/2NCT00196677
Study of Glaucoma Treatment With Food Additives
A Phase 1/2 study testing Vitamins, minerals and medical herbs in people with Glaucomatous Neuropathy, run by Future Products Management at 1 site in Israel.
Trial summary
The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Glaucomatous Neuropathy
- What is being tested?
- Vitamins, minerals and medical herbs
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Oct 2008
- Phase
- Phase 1/2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable open angle glaucoma - with equilibrated eye internal pressure
- Above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. Scoring of the vision field will be made according to the Agis study instructions.
Who cannot join
- Eye diseases excluding past cataract operation
- Allergy to one of the components in the preparation
- Deterioration in the vision field in the last year
- Kidney diseases, gastrointestinal (G.I.) tract, liver diseases, coagulation problems and thyroid diseases
- Persons who take steroids
- Diabetics or unbalanced hyperglycemia
Show all 12Show fewer
- Autoimmune diseases
- Hypertension (not responding to treatment)
- Psychiatric treatment with drugs, psychiatric pathologies
- Pregnancy
- Ability to take more than 3 pills per day regularly
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Glaucomatous Neuropathy With Food Additives
The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.
Read the detailed description
Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology.
- Conditions
- Glaucomatous Neuropathy
- Being tested
- Vitamins, minerals and medical herbs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamins, minerals and medical herbsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJul 2008
- Study completionOct 2008
Why it stopped: The trial was terminated due to investigator's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucomatous NeuropathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Products Management
- Sponsor type
- University, hospital or other
- Investigators
- Meir Gorban, MD, Study director, Future Products ManagementHani Levkovitch-Verbin, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196677
- Sponsor's protocol ID
- g88
- Status last verified
- Mar 2009
- First submitted
- 12 Sep 2005
- Last updated
- 11 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Glaucomatous Neuropathy With Food Additives
- ClinicalTrials.gov ID
- NCT00196677
- Acronym / sponsor ID
- g88
- Conditions
- Glaucomatous Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated due to investigator's decision
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Future Products ManagementUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.
Detailed description
Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable open angle glaucoma - with equilibrated eye internal pressure
- Above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. Scoring of the vision field will be made according to the Agis study instructions.
Key exclusion criteria (12 listed)
- Eye diseases excluding past cataract operation
- Allergy to one of the components in the preparation
- Deterioration in the vision field in the last year
- Kidney diseases, gastrointestinal (G.I.) tract, liver diseases, coagulation problems and thyroid diseases
- Persons who take steroids
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 |
|---|---|---|
| Vitamins, minerals and medical herbs | Drug | – |
Primary outcome
Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study
Results and safety
The study was stopped early (reason given: The trial was terminated due to investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
Related trials for Glaucomatous Neuropathy
RecruitingPhase 2
A Phase II Trial of G01 Eye Drops for Glaucomatous Optic Neuropathy
Primary Open-Angle Glaucoma, Optic Nerve Injury
Not yet recruiting
STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient
Optic Neuropathy
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.
Meir Gorban, MD study director
Future Products Management
Hani Levkovitch-Verbin, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamins, minerals and medical herbs in people with Glaucomatous Neuropathy, run by Future Products Management at 1 site in Israel.
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 2 inclusion and 12 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 11 Mar 2009. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: The trial was terminated due to investigator's decision). 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?
Improvement in vision field (Protocol24) in a Humphrey's instrument. Scoring according to the Agis study. 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 11 Mar 2009.