Photobiomodulation Therapy for Dry Age-Related Macular Degeneration: A Randomized Controlled Trial in South West Nigeria

Age-related macular degeneration (AMD) is the leading cause of central vision loss among the elderly in high-income countries, and its burden in Nigeria is rising with demographic aging. Photobiomodulation (PBM) therapy, using near-infrared light to stimulate retinal mitochondrial function, has emerged as a promising non-invasive intervention for dry AMD, but no randomized controlled trial (RCT) has evaluated PBM efficacy in an African population. This study conducts a double-masked, sham-controlled RCT of PBM therapy for dry AMD at three tertiary sites in Lagos, Ibadan, and Ile-Ife, South West Nigeria. One hundred and twenty patients with confirmed bilateral drusenoid dry AMD will be randomized 1:1 to active PBM or sham treatment, administered as three sessions weekly for three months. Primary outcomes include best-corrected visual acuity, macular sensitivity using microperimetry, and drusen volume on spectral-domain OCT at six months. Secondary outcomes include contrast sensitivity and vision-related quality of life. Intention-to-treat analysis will be conducted using linear mixed models. This trial represents the first evaluation of PBM therapy in the African context, where genetic differences in AMD pathogenesis and environmental exposures may modulate treatment response. Findings will be submitted to the Federal Ministry of Health and international AMD research groups to inform therapeutic access policy in Nigeria. Keywords: photobiomodulation, age-related macular degeneration, randomized controlled trial, South West Nigeria, retinal therapy