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.
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
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
Parallel
Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)
DeviceThe subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.
Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)
DeviceThe laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.
Changes in the retinal sensitivity - 12 months
Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 12 (unit of measure: dB)
Anatomical changes using structural optical coherence tomography (OCT)
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Rate of Progression
Rate of progression to advance AMD (GA and/or neovascular AMD)
Changes in the retinal sensitivity - 6 months
Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 6 (unit of measure: dB)
Anatomical changes using fundus autofluorescence (FAF)
Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF
Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients)
The % of AMD-associated single-nucleotide polymorphism (SNP) will be evaluated analyzing the % of patients with an AMD-associated SNP in patients showing no progression vs progression to advance AMD (main outcome 3).
Anatomical changes using OCT-angiography (OCT-A)
Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A
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Ospedale San Raffaele
Lead sponsor
Fondazione G.B. Bietti, IRCCS
Collaborator
University of Genova
Collaborator
University of Rome Tor Vergata
Collaborator
