Non-exsudative age-related macular degeneration
Conditions
Interventions
Product Name: Lutamax
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lutein
Other descriptive name: Lutamax
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-2
Sponsors
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery, Rudolf Foundation Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: § Study eye with non-exsudative AMD with > 10 large soft, and / or confluent drusen within 3000 nm of the foveal center - and a best corrected visual acuity using the ETDRS chart between 0,05 to 1,0 inclusive (Snellen 0,05 – 0,8) - with / without geographic atrophy less than 3 disc diameters within 3000 nm of the foveal center - with / without serous pigment epithelial detachment without clearly identifiable neovascularisation § Patients must have elevated baseline concentrations of at least one of the rheologic factors (serum cholesterol level > 200 mg/dL, fibrinogen level > 390 mg/dL, or plasmaviscosity > 1.6 mPa*s) § Patients with adequate bilateral anecubital venous access Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: § Study eye with exsudative AMD § Study eye with concomitant retinal or choroidal disorder other than AMD § Study eye with significant central lens opacities and / or conditions that limit the view of the fundus § Study eye with other ocular diseases § Patients who are in poor general health § Patients with a hematocrit < 30%, evidence of active bleeding, or a platelet count < 100,000 k/µL § Patients with significant cardiac problems § Patients with a history (< 12 months) of cardiac infarction § Patients with uncontrolled arterial hypertension § Patients with recent history (< 3 months) of cerebral vascular disease § Patients with uncontrolled diabetes § Patients who are allergic to fluorescein sodium and to indocyanine green § Patients who are unwilling to adhere to visit examination schedules § Patients with a known history of alcoholism, drug abuse, or any other condition that would limit hepatic function and validity of consent § Patients lutein supplement intake § Patients weighing < 45 kg § Patients with carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Visual acuity.;Secondary Objective: Lesion size, cholesterol and fibrinogen levels, plasma viscosity, lutein levels;Primary end point(s): Visual acuity | — |
Countries
Austria
Outcome results
None listed