Idiopathic Juxtafoveal TelangiectasiaNCT01354093
The Role of Macular Pigment Carotenoids in the Pathogenesis and Treatment of Macular Telangiectasia Type 2 (MacTel)
An observational study of Idiopathic Juxtafoveal Telangiectasia, run by Paul S. Bernstein at 1 site in United States.
Trial summary
Macular telangiectasia type 2 ("MacTel Type 2") is an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula is responsible for central or reading vision. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Idiopathic Juxtafoveal Telangiectasia
- What is being tested?
- zeaxanthin
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to ten subjects of either gender who have MacTel (as confirmed by the MacTel central study Reading Center) will be invited to participate. Only those who can conveniently travel to the University of Utah for study evaluations will be approached since the project does not have sufficient funding to reimburse for travel expenses. Participants must agree to discontinue use of any other supplements containing substantial amounts of carotenoids for one month prior to the baseline visit and for the duration of the study.
Who may be able to join
- Male or female subjects who have MacTel and can conveniently travel to the University of Utah for study evaluations
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Utah Center for the Collaborative Study of the Role of the Macular Pigment Carotenoids in the Pathogenesis and Treatment of MacTel
Macular telangiectasia type 2 ("MacTel Type 2") is an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula is responsible for central or reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.
The objectives of this study are to image the maculas of MacTel subjects using two-wavelength autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign, and to evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects
Read the detailed description
One of the earliest manifestations of macular telangiectasia type 2 ("MacTel") is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.
Dr. Bernstein's laboratory at the Moran Eye Center of the University of Utah has focused for the past fifteen years on the role of the macular pigment carotenoids, lutein and zeaxanthin, in maintaining macular health. These xanthophyll carotenoids are derived exclusively from the diet, especially from green leafy vegetables and orange-yellow fruits and vegetables. They are thought to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties. Dietary supplement products, from infant formula to those aimed at seniors, primarily contain lutein; however the central macula (the fovea) actually has been shown to have higher concentrations of zeaxanthin.
Dr. Bernstein's lab has identified and characterized the binding proteins responsible for the uptake and stabilization of lutein and zeaxanthin in the macula, developed new, noninvasive methods to quantify and image carotenoids in the retina and many other non-ocular tissues, and has participated in intervention trials of lutein and zeaxanthin against age-related macular degeneration. As a leading site for identification of MacTel families in North America as part of the "MacTel Project", Dr. Bernstein and other researchers at the University of Utah have unique expertise in the biochemistry and biophysics of the macular pigment carotenoids that may help to hasten progress toward effective diagnosis and intervention against MacTel in a highly collaborative manner.
Macular Pigment Imaging:
Dr. Bernstein has extensive experience with various methods to image and quantify macular pigment in the living human eye, especially using autofluorescence imaging (AFI) and resonance Raman imaging (RRI). Dr. Bernstein is also currently utilizing these methods to evaluate age-related macular degeneration (AMD) patients participating in the "AREDS2" study.
The objectives of this study are two-fold:
- To image the maculas of MacTel subjects using two-wavelength autofluorescence imaging (AFI) and resonance Raman imaging (RRI) to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign;
- To evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects.
This is an open-label pilot study that will enroll up to ten patients affected with macular telangiectasia type 2 and evaluate them every six months for two years. All participants will take 20 mg of zeaxanthin supplement per day for the duration of the study. Macular pigment distributions will be determined using two-wavelength autofluorescence imaging and resonance Raman imaging.
- Conditions
- Idiopathic Juxtafoveal Telangiectasia
- Being tested
- zeaxanthin
- Keywords
- MacTel, Macular telangiectasia type 2
- Medical subject headings
- Idiopathic Juxtafoveal Retinal Telangiectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zeaxanthinDrug
10 mg of EyePromise 10 (zeaxanthin) supplement, taken twice a day
zeaxanthinDrug
10 mg of EyePromise 10 (zeaxanthin) supplement, taken once a day
| Study group | Role | What they receive |
|---|---|---|
| MacTel Type 2 20 mg/day dose group | Participants will have macular telangiectasis type 2 as confirmed by the reading center. Participants will take 20 mg of zeaxanthin per day. Receives: Drug: zeaxanthin | |
| MacTel Type 2 10 mg/day dose group | Participants will have macular telangiectasia type 2 as confirmed by the reading center. Participants will take 10 mg of zeaxanthin per day. Receives: Drug: zeaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in macular pigment distribution and concentration
The primary outcome measure will be will be change from baseline in macular pigment distribution and concentration.
Measured: 1 year
Secondary outcomes (1)
Change in visual acuity
Secondary outcome measures will be best-corrected visual acuity, contrast sensitivity, and changes in retinal thickness measured by spectral domain OCT (optical coherence tomography).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Juxtafoveal TelangiectasiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul S. Bernstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul S. Bernstein, University of Utah
- Investigators
- Paul S. Bernstein, M.D., Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354093
- Sponsor's protocol ID
- 48834
- Status last verified
- Jun 2017
- First submitted
- 12 May 2011
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernstein PS, Delori FC, Richer S, van Kuijk FJ, Wenzel AJ. The value of measurement of macular carotenoid pigment optical densities and distributions in age-related macular degeneration and other retinal disorders. Vision Res. 2010 Mar 31;50(7):716-28. doi: 10.1016/j.visres.2009.10.014. Epub 2009 Oct 23.
PubMed 19854211Bhosale P, Li B, Sharifzadeh M, Gellermann W, Frederick JM, Tsuchida K, Bernstein PS. Purification and partial characterization of a lutein-binding protein from human retina. Biochemistry. 2009 Jun 9;48(22):4798-807. doi: 10.1021/bi9004478.
PubMed 19402606Sharifzadeh M, Zhao DY, Bernstein PS, Gellermann W. Resonance Raman imaging of macular pigment distributions in the human retina. J Opt Soc Am A Opt Image Sci Vis. 2008 Apr;25(4):947-57. doi: 10.1364/josaa.25.000947.
PubMed 18382494Loane E, Nolan JM, O'Donovan O, Bhosale P, Bernstein PS, Beatty S. Transport and retinal capture of lutein and zeaxanthin with reference to age-related macular degeneration. Surv Ophthalmol. 2008 Jan-Feb;53(1):68-81. doi: 10.1016/j.survophthal.2007.10.008.
PubMed 18191658Bhosale P, Bernstein PS. Vertebrate and invertebrate carotenoid-binding proteins. Arch Biochem Biophys. 2007 Feb 15;458(2):121-7. doi: 10.1016/j.abb.2006.10.005. Epub 2006 Oct 30.
PubMed 17188641Sharifzadeh M, Bernstein PS, Gellermann W. Nonmydriatic fluorescence-based quantitative imaging of human macular pigment distributions. J Opt Soc Am A Opt Image Sci Vis. 2006 Oct;23(10):2373-87. doi: 10.1364/josaa.23.002373.
PubMed 16985523Bhosale P, Larson AJ, Frederick JM, Southwick K, Thulin CD, Bernstein PS. Identification and characterization of a Pi isoform of glutathione S-transferase (GSTP1) as a zeaxanthin-binding protein in the macula of the human eye. J Biol Chem. 2004 Nov 19;279(47):49447-54. doi: 10.1074/jbc.M405334200. Epub 2004 Sep 7.
PubMed 15355982Bhosale P, Serban B, Zhao DY, Bernstein PS. Identification and metabolic transformations of carotenoids in ocular tissues of the Japanese quail Coturnix japonica. Biochemistry. 2007 Aug 7;46(31):9050-7. doi: 10.1021/bi700558f. Epub 2007 Jul 14.
PubMed 17630780
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utah Center for the Collaborative Study of the Role of the Macular Pigment Carotenoids in the Pathogenesis and Treatment of MacTel
- ClinicalTrials.gov ID
- NCT01354093
- Acronym / sponsor ID
- 48834
- Conditions
- Idiopathic Juxtafoveal Telangiectasia
- Keywords
- MacTel, Macular telangiectasia type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Paul S. BernsteinUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 May 2011 (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.
Macular telangiectasia type 2 ("MacTel Type 2") is an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula is responsible for central or reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.
The objectives of this study are to image the maculas of MacTel subjects using two-wavelength autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign, and to evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects
Detailed description
One of the earliest manifestations of macular telangiectasia type 2 ("MacTel") is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel.
Dr. Bernstein's laboratory at the Moran Eye Center of the University of Utah has focused for the past fifteen years on the role of the macular pigment carotenoids, lutein and zeaxanthin, in maintaining macular health. These xanthophyll carotenoids are derived exclusively from the diet, especially from green leafy vegetables and orange-yellow fruits and vegetables. They are thought to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties. Dietary supplement products, from infant formula to those aimed at seniors, primarily contain lutein; however the central macula (the fovea) actually has been shown to have higher concentrations of zeaxanthin.
Dr. Bernstein's lab has identified and characterized the binding proteins responsible for the uptake and stabilization of lutein and zeaxanthin in the macula, developed new, noninvasive methods to quantify and image carotenoids in the retina and many other non-ocular tissues, and has participated in intervention trials of lutein and zeaxanthin against age-related macular degeneration. As a leading site for identification of MacTel families in North America as part of the "MacTel Project", Dr. Bernstein and other researchers at the University of Utah have unique expertise in the biochemistry and biophysics of the macular pigment carotenoids that may help to hasten progress toward effective diagnosis and intervention against MacTel in a highly collaborative manner.
Macular Pigment Imaging:
Dr. Bernstein has extensive experience with various methods to image and quantify macular pigment in the living human eye, especially using autofluorescence imaging (AFI) and resonance Raman imaging (RRI). Dr. Bernstein is also currently utilizing these methods to evaluate age-related macular degeneration (AMD) patients participating in the "AREDS2" study.
The objectives of this study are two-fold:
- To image the maculas of MacTel subjects using two-wavelength autofluorescence imaging (AFI) and resonance Raman imaging (RRI) to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign;
- To evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects.
This is an open-label pilot study that will enroll up to ten patients affected with macular telangiectasia type 2 and evaluate them every six months for two years. All participants will take 20 mg of zeaxanthin supplement per day for the duration of the study. Macular pigment distributions will be determined using two-wavelength autofluorescence imaging and resonance Raman imaging.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MacTel Type 2 20 mg/day dose group | – | Drug: zeaxanthinParticipants will have macular telangiectasis type 2 as confirmed by the reading center. Participants will take 20 mg of zeaxanthin per day. |
| MacTel Type 2 10 mg/day dose group | – | Drug: zeaxanthinParticipants will have macular telangiectasia type 2 as confirmed by the reading center. Participants will take 10 mg of zeaxanthin per day. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to ten subjects of either gender who have MacTel (as confirmed by the MacTel central study Reading Center) will be invited to participate. Only those who can conveniently travel to the University of Utah for study evaluations will be approached since the project does not have sufficient funding to reimburse for travel expenses. Participants must agree to discontinue use of any other supplements containing substantial amounts of carotenoids for one month prior to the baseline visit and for the duration of the study.
Key inclusion criteria (1 listed)
- Male or female subjects who have MacTel and can conveniently travel to the University of Utah for study evaluations
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| zeaxanthin10 mg of EyePromise 10 (zeaxanthin) supplement, taken twice a day | Drug | MacTel Type 2 20 mg/day dose group |
| zeaxanthin10 mg of EyePromise 10 (zeaxanthin) supplement, taken once a day | Drug | MacTel Type 2 10 mg/day dose group |
Primary outcome
Change from baseline in macular pigment distribution and concentration
Time frame: 1 year
The primary outcome measure will be will be change from baseline in macular pigment distribution and concentration.
1 secondary outcome
Change in visual acuity
Time frame: 1 year
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 23 Jun 2017.
- Background: PubMed 19854211Bernstein PS, Delori FC, Richer S, van Kuijk FJ, Wenzel AJ. The value of measurement of macular carotenoid pigment optical densities and distributions in age-related macular degeneration and other retinal disorders. Vision Res. 2010 Mar 31;50(7):716-28. doi: 10.1016/j.visres.2009.10.014. Epub 2009 Oct 23.
- Background: PubMed 19402606Bhosale P, Li B, Sharifzadeh M, Gellermann W, Frederick JM, Tsuchida K, Bernstein PS. Purification and partial characterization of a lutein-binding protein from human retina. Biochemistry. 2009 Jun 9;48(22):4798-807. doi: 10.1021/bi9004478.
- Background: PubMed 18382494Sharifzadeh M, Zhao DY, Bernstein PS, Gellermann W. Resonance Raman imaging of macular pigment distributions in the human retina. J Opt Soc Am A Opt Image Sci Vis. 2008 Apr;25(4):947-57. doi: 10.1364/josaa.25.000947.
- Background: PubMed 18191658Loane E, Nolan JM, O'Donovan O, Bhosale P, Bernstein PS, Beatty S. Transport and retinal capture of lutein and zeaxanthin with reference to age-related macular degeneration. Surv Ophthalmol. 2008 Jan-Feb;53(1):68-81. doi: 10.1016/j.survophthal.2007.10.008.
- Background: PubMed 17188641Bhosale P, Bernstein PS. Vertebrate and invertebrate carotenoid-binding proteins. Arch Biochem Biophys. 2007 Feb 15;458(2):121-7. doi: 10.1016/j.abb.2006.10.005. Epub 2006 Oct 30.
- Background: PubMed 16985523Sharifzadeh M, Bernstein PS, Gellermann W. Nonmydriatic fluorescence-based quantitative imaging of human macular pigment distributions. J Opt Soc Am A Opt Image Sci Vis. 2006 Oct;23(10):2373-87. doi: 10.1364/josaa.23.002373.
- Background: PubMed 15355982Bhosale P, Larson AJ, Frederick JM, Southwick K, Thulin CD, Bernstein PS. Identification and characterization of a Pi isoform of glutathione S-transferase (GSTP1) as a zeaxanthin-binding protein in the macula of the human eye. J Biol Chem. 2004 Nov 19;279(47):49447-54. doi: 10.1074/jbc.M405334200. Epub 2004 Sep 7.
- Background: PubMed 17630780Bhosale P, Serban B, Zhao DY, Bernstein PS. Identification and metabolic transformations of carotenoids in ocular tissues of the Japanese quail Coturnix japonica. Biochemistry. 2007 Aug 7;46(31):9050-7. doi: 10.1021/bi700558f. Epub 2007 Jul 14.
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.
Paul S. Bernstein, M.D., Ph.D. principal investigator
University of Utah
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 Idiopathic Juxtafoveal Telangiectasia, run by Paul S. Bernstein 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 1 inclusion and 0 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 23 Jun 2017. 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?
Change from baseline in macular pigment distribution and concentration (time frame: 1 year). 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 NCT01354093, which also lists 8 linked publications.
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 23 Jun 2017.