MedTrace Logo

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

NCT04847635 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-12

No results posted yet for this study

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.

Conditions

  • Macular Degeneration, Senile
  • Laser Burn of Retina
  • Macular Degeneration Intermediate
  • Macular Degeneration, Dry

Interventions

DEVICE

Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)

The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.

DEVICE

Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)

The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.

Sponsors & Collaborators

  • Fondazione G.B. Bietti, IRCCS

    collaborator OTHER

  • University of Genova

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • Ospedale San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2026-09-01
Completion
2026-09-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847635 on ClinicalTrials.gov