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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

• Ability to provide informed consent and attend all study visits

Locations
Other Locations
Italy
Massimo Nicolò
RECRUITING
Genova
Giuseppe Querques
RECRUITING
Milan
Mariacristina Parravano
RECRUITING
Rome
Contact Information
Primary
Giuseppe Querques, MD, PhD
querques.giuseppe@hsr.it
+390226434004
Time Frame
Start Date: 2021-03-16
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 50
Treatments
Experimental: Subthreshold laser group
To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen.
Sham_comparator: Sham group
The light from the retinal illumination system on the laser device will be used instead of the laser beam in all follow-up evaluations.
Sponsors
Collaborators: University of Genova, University of Rome Tor Vergata, Fondazione G.B. Bietti, IRCCS
Leads: Ospedale San Raffaele

This content was sourced from clinicaltrials.gov