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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorOspedale San Raffaele

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

50 Participants
are divided into 2 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