Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab)

Randomized, three-group, parallel comparative study on changes in macular pigment optical density and visual function due to administration of supplements containing lutein and omega3 fatty acids to patients with age-related macular degeneration (patients treated with ranibizumab) - The comparative study on the effects of lutein and omega3 fatty acids supplements to age-related macular degeneration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004804

Enrollment

120

Registered

2010-12-28

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

age-related macular degeneration

Interventions

multivitamins and minerals (M&amp

M) multivitamins and minerals plus a lutein supplement (M&amp

M + lutein) multivitamins and minerals plus supplements containing lutein + omega3 fatty acids (M&amp

M + lutein + omega3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Exudative age-related macular degeneration with subfoveal choroidal neovascularization. However, eyes with retinal angiomatous proliferation (RAP) will be excluded (2)Eyes with improvement in exudative changes after receiving 3 injections of intravitreal ranibizumab (Lucentis) Improvement is defined as a decrease in central retinal thickness by at least 100um (as measured by OCT-3000). (3)Start of the study within 1-2 months of the last injection of intravitreal ranibizumab (4)Visual Acuity is more than 50 ETDRS letters (0.2) (5)Aged 50 years or older at provision of informed consent, and has given consent in writing (6)Male or female (7)Judged by the investigator to be eligible as a subject on the basis of screening tests (8)Not allergic to lutein or omega3 fatty acids

Exclusion criteria

Exclusion criteria: (1) Presence of cataracts of a severity sufficient to materially affect the above evaluations of visual function (2)Undergone cataract surgery within the previous 3 months (3)Pupile size of less than 6.5 mm (4)Presence of glaucoma, diabetic retinopathy, or other serious disease of the fundus (5)Myopia of -6D or higher (6)Presence of hepatopathy, nephropathy, or cardiac disease of a severity sufficient to affect the evaluations of the supplements to be taken by patients (7)Receiving photosensitive drugs such as phenothiazine, chloroquine, and tetracycline on an ongoing basis (8)Regular use of lutein or DHA in the past 3 months (9)Judged by the investigator to be ineligible for other reasons

Design outcomes

Primary

Measure	Time frame
Macular pigment optical density	—

Secondary

Measure	Time frame
(1)Frequency of retreatment with intravitreal ranibizumab (2)Ophthalmological evaluations Essential: Visual acuity (using an ETDRS visual acuity chart), slit-lamp microscopy and funduscopy under mydriasis, color fundus photography, fluorescein and indocyanine green angiography, central retinal thickness as measured by optical coherence tomography (OCT-3000) Optional: Measurement of contrast sensitivity, measurement of glare sensitivity, Humphrey field analyzer (10-2), M-chart (3)Plasma lutein,DHA concentration	—

Measure

Time frame

(1)Frequency of retreatment with intravitreal ranibizumab (2)Ophthalmological evaluations Essential: Visual acuity (using an ETDRS visual acuity chart), slit-lamp microscopy and funduscopy under mydriasis, color fundus photography, fluorescein and indocyanine green angiography, central retinal thickness as measured by optical coherence tomography (OCT-3000) Optional: Measurement of contrast sensitivity, measurement of glare sensitivity, Humphrey field analyzer (10-2), M-chart (3)Plasma lutein,DHA concentration

—

Countries

Japan

Contacts

Public ContactMasahiro Asano

Seirei Hamamatsu General Hospital (Shizuoka Prefecture) Department of Ophthalmology

ryoasa0120@googlemail.com053-474-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026