Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD

NCT02800356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-20

Study results available
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Summary

To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.

Conditions

Interventions

PROCEDURE

Subthreshold 577 nm yellow wavelength laser photo-coagulator

Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed. The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Principal Investigators

  • Giuseppe Querques, MD, PhD · Ospedale San Raffaele

  • Riccardo Sacconi, MD · Ospedale San Raffaele

  • Francesco Gelormini, MDs · Ospedale San Raffaele

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • Italy

Study Locations

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Entities

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 NCT02800356 on ClinicalTrials.gov