Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration

Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.

NCT Number	NCT04847635
Lead Sponsor	Ospedale San Raffaele Collaborators: Fondazione G.B. Bietti, IRCCS, University of Genova, University of Rome Tor Vergata
Conditions	Macular Degeneration, Senile, Laser Burn of Retina, Macular Degeneration Intermediate, Macular Degeneration, Dry
Enrollment	50 participants
Start Date	2021-03-16
Primary Completion	2026-09-01 (estimated)
Study Completion	2026-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-12