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The anti-oxidant effect of vitamin D and homotaurine on progression of early-intermediate age related macular degeneration

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Posterboard#: B0258

Abstract Number: 1789 - B0258

AuthorBlock: Flavia Chiosi1, Emma Minutillo1, Michele Rinaldi2, Otello Gallo1, Gianluigi Manzi1
1Ophthalmology, Ospedali dei Colli-Monaldi-Napoli, Napoli, Napoli, Italy; 2Ophthalmology, Università degli studi della Campania Luigi Vanvitelli, , Italy;

DisclosureBlock: Flavia Chiosi, None; Emma Minutillo, None; Michele Rinaldi, None; Otello Gallo, None; Gianluigi Manzi, None;

Purpose
Drusen are hallmarks of age-related macular degeneration (AMD). In literature it has been evidenced that amyloid-beta (Aβ), the peptide associated with neurodegenerative events in Alzheimer’s disease, is an important constituent of drusen.
Homotaurine and vitamin D have been shown to bind Aβ and inhibit its induced neurotoxicity in retinal cellular assays.
We decided to perform a prospective, double blind , placebo-controlled study to test the efficacy of vitamin D and homotaurine in patients affected by early-intermediate AMD.

Methods
Fifty-three patients affected by early-intermediate AMD were enrolled in the study and randomized (2:1) to receive 1 tablet/day of a nutritional supplement containing a mixture of vitamin D 50 μg (1000%), homotaurine 50 mg plus complete AREDS 2 formula or placebo for 12 months.
AMD progression was assessed by optical coherence tomography changes in drusen size (primary outcome), retinography, Amsler test, visual function quality test (NEI-VFQ), best corrected visual acuity (BCVA) for distance and near. Main inclusion criteria were: diagnosis of early-intermediate AMD according to AREDS classification; presence of small-medium drusen (≥ 63 μm, < 125 μm) in macular zone; BCVA for distance ≥ 20/32 ETDRS charts; BCVA for near ≥ 20/32 Snellen Decimal (LogMar 0.2) at the MNREAD chart. Main exclusion criteria were: myopia > 3 diopter; other macular disorders; cataract and eye surgery 3 months prior to enrollment study.
Differences in the two arms were evaluated using chi-square test or Fisher’s exact test.

Results
Fifty patients completed the follow-up at 12 months. An AMD progression was observed in 2.5 % of patients of the treated arm and in 19.4 % of patients in the placebo arm (p = 0.05, Fisher’s exact test). No significant difference was found in BCVA between the placebo (51.6±6.3 letters) and treated arm (53.4 ± 5.6 letters), while a statistically significant reduction ( p= 0.05) in drusen size was observed in treated group (mean reduction 6.5 μm from baseline) versus placebo (0 μm from baseline).

Conclusions
Our results are consistent with the hypothesis that vitamin D and homotaurine, along with AREDS 2 formulation, can further reduce the progression of AMD in patients affected by early-intermediate stage disease, decreasing the presence of Aβ in drusen.

Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.