Hydroxychloroquine Treatment Linked to Less Visual Deterioration Among AMD Eyes

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New results from The HIT study, a double-blind, randomized controlled trial, suggested patients with age-related macular degeneration (AMD) treated with hydroxychloroquine experienced less visual acuity deterioration at two-year follow-up compared with those treated with placebo.¹

The investigative team from the Ben-Gurion University of the Negev found the growth and amount of drusen formation 2 years after treatment initiation was less among those treated with hydroxychloroquine. The team, led by Tal Yahalomi, MD, additionally observed a negative association between hydroxychloroquine treatment and wet AMD development.

“Though previous studies suggested an anti-inflammatory effect of HCQ in preventing AMD, this prospective study showed reduced growth of drusen in patients treated with HCQ compared to a placebo,” investigators wrote. “The latter process is recognized as a predisposing factor of AMD.”

Previously reported data showed patients with rheumatoid arthritis treated with hydroxychloroquine may experience a protective measure against the development of AMD, potentially due to the anti-inflammatory action of the drug. In the HIT study, investigators assessed the number of drusen, growth of drusen, and visual acuity two years after initiation of one-year treatment with hydroxychloroquine or placebo in individuals with AMD.

The inclusion criteria consisted of AMD with persistent drusen, categorized according to ARDS categories 2 and 3, and with GA or prior ocular surgery. Each patient received a daily dosage of 400 mg hydroxychloroquine (study group) or placebo (control group). For the purpose of analysis, all underwent a complete ophthalmic examination at months 3, 6, 9, 12, and 24 months after initiation of treatment, and follow-up was extended to 12 months following treatment completion (up to 2 years after study start).

Of 110 patients enrolled in the study, 55 were randomized to the hydroxychloroquine treatment group and 55 were randomized to the control group. From this population, 46 patients (29 females, 63%) in the study group and 50 patients (29 females, 58%) in the control group completed the study and did not differ in their ocular characteristics.

Upon analysis, visual acuity deterioration at 2-year follow-up compared to baseline was less in the hydroxychloroquine group than in the control group (−0.03 ± 0.07 vs. −0.07 ± 0.07, P = 0.027). Additionally, at the 2-year follow-up, the difference between the hydroxychloroquine and control groups was not statistically significant in increased central macular thickness (P = .21).

At 2 years after treatment initiation, data showed the mean number of drusen per eye was lower in the hydroxychloroquine group than the control group for ARDS2 (8.1 vs. 12.3; P = .045) and similar between groups of ARDS3 (7.4 vs. 9.2; P = .87). Overall, the proportion of eyes with total drusen growth was also lower in the hydroxychloroquine group than the control group (32 of 46 eyes [70%] vs. 40 of 50 eyes [80%]).

The analysis showed drusen volume growth, as measured by area and height with macular optical coherence tomography (OCT), was additionally lower in the hydroxychloroquine group than the control group (0.20 ± 0.15 vs. 0.23 ± 0.16 mm⁴, P = 0.05). Despite hydroxychloroquine being linked to retinal toxicity, none of the participants showed hydroxychloroquine toxicity or systemic adverse effects, according to investigators.

“Nonetheless, individuals using the drug should be followed for toxic retinopathy,” investigators wrote. “We strongly recommend a follow-up routine for patients using hydroxychloroquine, in addition to a thorough examination and medical history of anamnesis before starting treatment.”

References

1. Yahalomi T, Pikkel Y, Arnon R, Porat D, Pikkel J. The HIT Study-The Hydroxychloroquine Effect in the Treatment of Patients with Age-Related Macular Degeneration: A Randomized Controlled Trial. Medicina (Kaunas). 2023;59(3):551. Published 2023 Mar 11. doi:10.3390/medicina59030551