About this trial
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.
Eligibility criteria
Qualifiers
50 years or older
Presence of RPD secondary to AMD
Best-corrected visual acuity (BCVA) between 20/20 and 20/400 inclusive
Clear ocular media
Disqualifiers
Presence of Geographic Atrophy (GA)
Evidence of choroidal neovascularization in either eye
Any prior treatment for AMD, aside from antioxidants
Any corneal opacity, cataract formation and hemorrhage in the vitreous body, which may interfere with viewing by the laser surgeon of the target structures
Trial design
Treatments tested in this trial
- Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)
- Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)
Treatment groups
Sponsors and collaborators
Ospedale San Raffaele
Lead sponsor
Fondazione G.B. Bietti, IRCCS
Collaborator
University of Genova
Collaborator
University of Rome Tor Vergata
Collaborator