The Role of Macular Pigment Carotenoids in the Pathogenesis and Treatment of Macular Telangiectasia Type 2 (MacTel)

NCT01354093 | Completed DMC

• 1 other identifier: 48834
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Idiopathic Juxtafoveal Telangiectasia

Keywords

MacTel; Macular telangiectasia type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Change in visual acuity

  1 year

Study Arms (2)

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.

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.

Drug: zeaxanthin

Interventions

zeaxanthin DRUG

10 mg of EyePromise 10 (zeaxanthin) supplement, taken twice a day

MacTel Type 2 20 mg/day dose group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Male or female subjects who have MacTel and can conveniently travel to the University of Utah for study evaluations

Sponsors & Collaborators

• Paul S. Bernstein: lead

Study Sites (1)

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (8)

• 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.

  PMID: 19854211 BACKGROUND

• Bhosale 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.

  PMID: 19402606 BACKGROUND

• Sharifzadeh 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.

  PMID: 18382494 BACKGROUND

• Loane 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.

  PMID: 18191658 BACKGROUND

• Bhosale 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.

  PMID: 17188641 BACKGROUND

• Sharifzadeh 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.

  PMID: 16985523 BACKGROUND

• Bhosale 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.

  PMID: 15355982 BACKGROUND

• Bhosale 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.

  PMID: 17630780 BACKGROUND

MeSH Terms

Conditions

Idiopathic Juxtafoveal Retinal Telangiectasia

Interventions

Zeaxanthins

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Paul S. Bernstein, M.D., Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 16, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

US (1)