Retinal Vein OcclusionPhase 2/3NCT00493064
To Study the Effectiveness and Safety of Niacin and a Topical Steroid Eye Drop to Treat Retinal Vein Occlusions
A Phase 2/3 study testing Nicotinic acid and Prednisolone acetate in people with Retinal Vein Occlusion, run by Palo Alto Medical Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Nicotinic acid and Prednisolone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be able to understand the study procedures, agree to participate, and give written consent.
- Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.
- Patients must be able to follow the study medication regimen.
- Patients must agree to return for the once monthly eye exams.
- Patients must agree to have liver function tests performed on a regular basis.
- Patients must agree to have regular appointments with their Internist on an established basis.
Who cannot join
- Patients with active Gout, or high levels of Uric
- Patients may not be pregnant or lactating.
- The Principal Investigator reserves the right to exclude any patient who he feels will not make a good candidate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation Department of Ophthalmology
Palo Alto, California, 94301
About this study
Official title: Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO
The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.
Read the detailed description
The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vein occlusion that are being studied include central (CRVO), hemi-retinal (HRVO), and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide)a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Nicotinic acid, Prednisolone acetate
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinic acidDrug
Also called Niacin
topical eye drops
Prednisolone acetateDrug
topical eye drops
| Study group | Role | What they receive |
|---|---|---|
| Prospective active treatment | Experimental | Niacin 500mg TID PO for treatment of retinal vein occlusions. Receives: Drug: Nicotinic acid; Drug: Prednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
improvement with combination of niacin and topical prednisolone acetate
Measured: one year
Secondary outcomes (1)
A Decrease in the Thickness of the Retina
data not available
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal Vein OcclusionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Gaynon, MD, Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493064
- Sponsor's protocol ID
- 06-21
- Status last verified
- Dec 2018
- First submitted
- 25 Jun 2007
- Last updated
- 21 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO
- ClinicalTrials.gov ID
- NCT00493064
- Acronym / sponsor ID
- 06-21
- Conditions
- Retinal Vein Occlusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 21 Dec 2018
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 whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.
Detailed description
The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vein occlusion that are being studied include central (CRVO), hemi-retinal (HRVO), and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide)a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective active treatment | Experimental | Drug: Nicotinic acid, Drug: Prednisolone acetateNiacin 500mg TID PO for treatment of retinal vein occlusions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be able to understand the study procedures, agree to participate, and give written consent.
- Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.
- Patients must be able to follow the study medication regimen.
- Patients must agree to return for the once monthly eye exams.
- Patients must agree to have liver function tests performed on a regular basis.
Key exclusion criteria (3 listed)
- Patients with active Gout, or high levels of Uric
- Patients may not be pregnant or lactating.
- The Principal Investigator reserves the right to exclude any patient who he feels will not make a good candidate.
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 |
|---|---|---|
| Nicotinic acidAlso: Niacintopical eye drops | Drug | Prospective active treatment |
| Prednisolone acetatetopical eye drops | Drug | Prospective active treatment |
Primary outcome
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
Time frame: one year
improvement with combination of niacin and topical prednisolone acetate
1 secondary outcome
A Decrease in the Thickness of the Retina
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
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Retinal Vein Occlusion (RVO)
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.
Michael Gaynon, MD principal investigator
Palo Alto Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nicotinic acid and Prednisolone acetate in people with Retinal Vein Occlusion, run by Palo Alto Medical Foundation 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 21 Dec 2018. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart. (time frame: one year). 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 21 Dec 2018.