Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00568828 |
| Other study ID # |
MacTEL Supplement |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
December 5, 2007 |
| Last updated |
December 5, 2007 |
| Start date |
December 2007 |
| Est. completion date |
February 2008 |
Study information
| Verified date |
December 2007 |
| Source |
The Lowy Medical Research Institute Limited |
| Contact |
Daniel Pauleikhoff, MD |
| Phone |
49-251-933080 |
| Email |
dapauleikhoff[@]muenster.de |
| Is FDA regulated |
No |
| Health authority |
Germany: Federal Institute for Drugs and Medical Devices |
| Study type |
Observational
|
Clinical Trial Summary
Earlier investigations have detected low levels of macular pigment (MP) in the center of the
fovea and a halo of MP at a higher eccentricity in persons with type 2 idiopathic
juxtafoveal teleangiectasia (MACTEL)[Helb H-M, Charbel Issa P, Pauleikhoff D, Scholl HPN,
Holz FG, MacTel-Study Group. Macular Pigment Density and Distribution in Patients with
Macular Telangiectasia. ARVO Annual Meeting 2006, Fort Lauderdale, 30.04.-5.05.2006. Program
# 5701/B795]. To date it is not known whether the total MP is reduced in MACTEL or whether
even more MP accumulates at higher eccenticities compared to healthy probands. With the
suggested study we aim to
1. investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2. investigate and quantify MP at the posterior pole of MACTEL probands
3. detect possible changes of MP concentration and distribution following supplementation
with Lutein and Zeaxanthin
Description:
Rationale for performing this study Earlier investigations have detected low levels of
macular pigment (MP) in the center of the fovea and a halo of MP at a higher eccentricity in
persons with type 2 idiopathic juxtafoveal teleangiectasia (MACTEL)[Helb H-M, Charbel Issa
P, Pauleikhoff D, Scholl HPN, Holz FG, MacTel-Study Group. Macular Pigment Density and
Distribution in Patients with Macular Telangiectasia. ARVO Annual Meeting 2006, Fort
Lauderdale, 30.04.-5.05.2006. Program # 5701/B795]. To date it is not known whether the
total MP is reduced in MACTEL or whether even more MP accumulates at higher eccenticities
compared to healthy probands. With the suggested study we aim to
1. investigate Lutein and Zeaxanthin serum levels in MACTEL probands
2. investigate and quantify MP at the posterior pole of MACTEL probands
3. detect possible changes of MP concentration and distribution following supplementation
with Lutein and Zeaxanthin
The suggested study During this study we plan to select at least 10 MACTEL probands with
different patterns of MP distribution including
1. those with detectable accumulation of MP in the center and segmental reduction of MP
temporally
2. those with nearly no central accumulation and and larger area of reduced MP temporally
3. those with no detectable accumulation of MP in the center and a halo of MP at a more
eccentric location These probands will be supplemented with Lutein (L) and Zeaxanthin
(Z) (12mg L and 1 mg Z, provided as esters, 120mg Vitamin C, 17.6 mg Vitamin E, 10mg
Zink, 40µg Selen (Ocuvite Lutein™)) for a duration of nine months. During the
supplementation and three months after stop of supplementation, probands will be
investigated every three months including
1. ophthalmologic investigation, 2. fundus photography, 3. measurement of MP with a modified
Heidelberg retina Angiograph employing two excitation wavelengths (514 and 488nm) 4.
measurement of L and Z in serum.
Aim of the study
1. Investigation of changes of MP concentration and distribution following supplementation
of L and Z in MACTEl probands
2. How do serum levels of L and Z change in these probands?
Visit:
V1 Screening & Start of supplementat V2 V3 V4 End of supplemenation V5 after stop of intake
Months 0 3 6 9 12 general Informed consent X Medical history X in- and exclusion criteria X
concommitant medication X X X X X Adverse events X X X X Pill count X X X Vital signs/ BMI X
X Slitlamp investigation X X X X X Fundusphotography X X Visual acuity X X X X X
Supplementation X X X Measurement of Xanthophylls Eye: MPOD (HRA) X X X X X Food frequency
questionnaire X X Blood collection For (Heparin) Plasma to quantify Xanthophylls and Lipids
X X X X X
Probands resident within a perimeter of 40km around the clinic will be preferentially
selected to lower travel expenses. Recruitment takles place during regular visits in the
course of the MACTEL study. For the angiography a vein will be punctated so that no
additional punction is needed. Serum ist centrifuged at 1500g for 15min and kept at -70°C
until analyse. Analyse of the Xanthophylls and Lipids in serum will be performed at the
central laboratory of the University of Münster.
Autofluorescence imaging is part of study protocol for MACTEL Study. Two main images will be
taken, one with an excitation wavelength of 488nm (good absorption by MP) and one with 514nm
(poor absorption by MP). The digital subtration of both images provides a map of MP density
around the fovea.
Inclusion criteria Informed consent Age at least 18y.? Type 2 IMT? Healthy general
condition? At least one eye free from lens- or retina problems interfering with MP
measurement with the modofied Heidelberg retina angiograph? Exclusion criteria No informed
consent ? Younger than als 18 y.? Intake of Supplements containing L and Z (> 3mg L und >1mg
Z) during the last 6 months? Bad general condition/ unintended loss of weight (>10%) within
the last 3 monhs?
