Exudative Age-Related Macular DegenerationARMDNCT01527435
Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD)
An observational study of Exudative Age-Related Macular Degeneration, run by The Retina Center of St. Louis County, PC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the fact that 20 milligrams per day of oral Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative age related macular degeneration (ARMD) undergoing combination therapy with intravitreal Bevacizumab (Avastin), intravitreal Dexamethasone… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2015
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Male or female at least 50 years of age. 2. Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye. 3. Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen). 4. Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment. 5. Written and informed consent has been obtained. 6. Written authorization for the use and release of the health and research study information in the United States of America USA. 7. Ability to understand the informed consent and willingness to follow study instruction and likely to complete all required visits and procedures.
Who may be able to join
- Male or female at least 50 years of age.
- Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye.
- Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen).
- Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment.
- Written and informed consent has been obtained.
- Written authorization for the use and release of the health and research study information in the United States of America USA.
- Ability to understand the informed consent and willingness to follow study instruction and likely to complete all required visits and procedures.
Who cannot join
- Evidence of diabetic retinopathy or other retinal disease other than age related macular degeneration.
- Any severe active ocular disease or condition that in the opinion of the investigator is severe enough to prevent a 3 line improvement in visual acuity or to compromise the study results.
- Any presumed ocular infections, i.e. bacterial, viral, parasitic, or fungal in either eye at the baseline visit.
- Contraindication to pupillary dilation in either eye.
- Uncontrolled systemic disease.
- Any condition (including inability to read visual acuity charts and language barriers) which precludes subjects ability to comply with the study requirements including the completion of the study.
- Subject has a condition or is in a situation which the investigator's opinion may put the subject at significant risk, may confound the study results or may interfere significantly with the subjects participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)
The purpose of this study is to evaluate the fact that 20 milligrams per day of oral Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative age related macular degeneration (ARMD) undergoing combination therapy with intravitreal Bevacizumab (Avastin), intravitreal Dexamethasone and PDT laser photocoagulation and improves anatomic and visual outcome compared to patients not receiving oral Zeaxanthin. Study patients will be taking AREDS(PreserVision) and multivitamins (Centrum Silver); in addition one-half of the patients will receive 20mg of oral Zeaxanthin.
Read the detailed description
One of the current treatments for choroidal neovascularization in exudative age related macular degeneration (ARMD) involves a combination of laser photocoagulation (PDT) and injections of an anti-inflammatory (Dexamethasone) and an anti-angiogenic (Bevacizumab). This combination therapy is designed to stabilize vision, improve vision in selected cases and reduce the total number of treatment cycles overall compared to other methods of treatment presently in use. Many retinal physicians are treating exudative ARMD with an ocular injection every 4 weeks for a number of years. Combination therapy has reduced the number of treatment cycles to less than 3 for many patients; and in preliminary studies, patients taking 20 milligrams of dietary oral zeaxanthin required even less treatment cycles to achieve stability. In this trial, the only variable will be the oral consumption of 20 milligrams of zeaxanthin daily taken in half of the patients randomized to this group. The remaining half patients with still undergo combination therapy, but without taking 20 milligrams of oral dietary Zeaxanthin.
Zeazanthin is found in many foods and low doses of zeazanthin are commonly added to many multivitamins already on the market. All products with Zeazanthin is a constituent, including EyePromise Ten, have excellent safety profiles and no side effects or adverse events have been reported thus far with this supplement.
Zeazanthin is in many eye supplements and is being studied by the NEI, National Eye Institute, as part of the AREDS-2 study looking at the benefits of Lutein, Zeazanthin and Omega 3 Fish Oils on AMD progression. The patients will be taking 20 milligrams a day of Zeazanthin. The United States and global safety organization have established an ADI (acceptable daily intake) of 2 mg/kg body weight/day of Zeazanthin. This equates to 155 mg per day for 177 pound person.
Millions of doses of EyePromise Ten have been taken without side effects. The new part of this trial, again is taking 20 milligrams of Zeazanthin while being combined with medical injections and laser treatments. Zeazanthin is one of the two pigments obtained from the diet that deposit in the macula and give it the yellow color. While obtained from the diet the retina accumulates it up to 1000 times higher levels than anywhere else in the body. Numerous scientific and clinical trials suggest that it is critical to the protection of the retina and in reducing risks and progression of age related macular degeneration.
- Keywords
- Best corrected visual acuity, Slit lamp examination, Ophthalmoscopy with contact lens/indirect ophthalmoscope, OCT assessment, Fundus photos, fluorescein angiogram, ICG angiogram
What is being measured
The primary outcome is the main question the study is designed to answer.
BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS
BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS WITH THOSE ON SUPPLEMENTS VERSUS BEST CORRECTED VISUAL ACUITY OF THOSE WHO JUST RECEIVED TREATMENTS
Measured: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exudative Age-Related Macular DegenerationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Retina Center of St. Louis County, PC
- Sponsor type
- University, hospital or other
- Collaborators
- ZeaVision, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert J Olk, MD, Principal investigator, The Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527435
- Sponsor's protocol ID
- 11-06-0044
- Acronym
- ARMD
- Status last verified
- Apr 2016
- First submitted
- 27 Jan 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown GC, Brown MM, Gierhart D, Olk RJ. Prevention Surpasses Treatment: 5-year Follow-Up, Cost-Utility, and Cost-Benefit of Zeaxanthin Therapy for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Oct;12(5):2583-2608. doi: 10.1007/s40123-023-00742-9. Epub 2023 Jul 10.
PubMed 37430077
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)
- ClinicalTrials.gov ID
- NCT01527435
- Acronym / sponsor ID
- ARMD / 11-06-0044
- Keywords
- Best corrected visual acuity, Slit lamp examination, Ophthalmoscopy with contact lens/indirect ophthalmoscope, OCT assessment, Fundus photos, fluorescein angiogram, ICG angiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Retina Center of St. Louis County, PCUniversity, hospital or other
- Collaborators
- ZeaVision, Inc.
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Feb 2012 (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 evaluate the fact that 20 milligrams per day of oral Zeaxanthin as a supplement to patients with Choroidal neovascularization (CNV) and exudative age related macular degeneration (ARMD) undergoing combination therapy with intravitreal Bevacizumab (Avastin), intravitreal Dexamethasone and PDT laser photocoagulation and improves anatomic and visual outcome compared to patients not receiving oral Zeaxanthin. Study patients will be taking AREDS(PreserVision) and multivitamins (Centrum Silver); in addition one-half of the patients will receive 20mg of oral Zeaxanthin.
Detailed description
One of the current treatments for choroidal neovascularization in exudative age related macular degeneration (ARMD) involves a combination of laser photocoagulation (PDT) and injections of an anti-inflammatory (Dexamethasone) and an anti-angiogenic (Bevacizumab). This combination therapy is designed to stabilize vision, improve vision in selected cases and reduce the total number of treatment cycles overall compared to other methods of treatment presently in use. Many retinal physicians are treating exudative ARMD with an ocular injection every 4 weeks for a number of years. Combination therapy has reduced the number of treatment cycles to less than 3 for many patients; and in preliminary studies, patients taking 20 milligrams of dietary oral zeaxanthin required even less treatment cycles to achieve stability. In this trial, the only variable will be the oral consumption of 20 milligrams of zeaxanthin daily taken in half of the patients randomized to this group. The remaining half patients with still undergo combination therapy, but without taking 20 milligrams of oral dietary Zeaxanthin.
Zeazanthin is found in many foods and low doses of zeazanthin are commonly added to many multivitamins already on the market. All products with Zeazanthin is a constituent, including EyePromise Ten, have excellent safety profiles and no side effects or adverse events have been reported thus far with this supplement.
Zeazanthin is in many eye supplements and is being studied by the NEI, National Eye Institute, as part of the AREDS-2 study looking at the benefits of Lutein, Zeazanthin and Omega 3 Fish Oils on AMD progression. The patients will be taking 20 milligrams a day of Zeazanthin. The United States and global safety organization have established an ADI (acceptable daily intake) of 2 mg/kg body weight/day of Zeazanthin. This equates to 155 mg per day for 177 pound person.
Millions of doses of EyePromise Ten have been taken without side effects. The new part of this trial, again is taking 20 milligrams of Zeazanthin while being combined with medical injections and laser treatments. Zeazanthin is one of the two pigments obtained from the diet that deposit in the macula and give it the yellow color. While obtained from the diet the retina accumulates it up to 1000 times higher levels than anywhere else in the body. Numerous scientific and clinical trials suggest that it is critical to the protection of the retina and in reducing risks and progression of age related macular degeneration.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Male or female at least 50 years of age. 2. Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye. 3. Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen). 4. Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment. 5. Written and informed consent has been obtained. 6. Written authorization for the use and release of the health and research study information in the United States of America USA. 7. Ability to understand the informed consent and willingness to follow study instruction and likely to complete all required visits and procedures.
Key inclusion criteria (7 listed)
- Male or female at least 50 years of age.
- Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye.
- Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen).
- Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment.
- Written and informed consent has been obtained.
Key exclusion criteria (7 listed)
- Evidence of diabetic retinopathy or other retinal disease other than age related macular degeneration.
- Any severe active ocular disease or condition that in the opinion of the investigator is severe enough to prevent a 3 line improvement in visual acuity or to compromise the study results.
- Any presumed ocular infections, i.e. bacterial, viral, parasitic, or fungal in either eye at the baseline visit.
- Contraindication to pupillary dilation in either eye.
- Uncontrolled systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS
Time frame: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY
BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS WITH THOSE ON SUPPLEMENTS VERSUS BEST CORRECTED VISUAL ACUITY OF THOSE WHO JUST RECEIVED TREATMENTS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 37430077Brown GC, Brown MM, Gierhart D, Olk RJ. Prevention Surpasses Treatment: 5-year Follow-Up, Cost-Utility, and Cost-Benefit of Zeaxanthin Therapy for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Oct;12(5):2583-2608. doi: 10.1007/s40123-023-00742-9. Epub 2023 Jul 10.
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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 J Olk, MD principal investigator
The Retina Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-Related Macular Degeneration, run by The Retina Center of St. Louis County, PC 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 7 inclusion and 7 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 6 Apr 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS (time frame: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527435, which also lists 1 linked publication.
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 6 Apr 2016.