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

NCT04847635 | Recruiting DMC

• 1 other identifier: PASCAL-RPD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Retina; Age-related macular degeneration; Reticular pseudodrusen; Sub-threshold laser

Outcome Measures

Primary Outcomes (3)

• 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)

  12 months

• Anatomical changes using structural optical coherence tomography (OCT)

  Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)

  12 months

• Rate of Progression

  Rate of progression to advance AMD (GA and/or neovascular AMD)

  12 months

Secondary Outcomes (4)

• Changes in the retinal sensitivity - 6 months

  6 months

• Anatomical changes using fundus autofluorescence (FAF)

  12 months

• Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients)

  12 months

• Anatomical changes using OCT-angiography (OCT-A)

  12 months

Study Arms (2)

Subthreshold laser group

EXPERIMENTAL

To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen.

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

Sham group

SHAM COMPARATOR

The light from the retinal illumination system on the laser device will be used instead of the laser beam in all follow-up evaluations.

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

Interventions

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

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

Subthreshold laser group

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

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

Sham group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Aphakic eye with vitreous in the anterior chamber
• Neovascular Glaucoma
• Glaucoma caused by congenital angle anomalies
• Open angle of less than 90º or extensive peripheral anterior and low synechia, present circumferentially around the corner
• Significant corneal edema or reduced water clarity that obscures the view angle in detail
• Glaucoma secondary to active uveitis
• Any other ocular condition that would progress in the study period and confound visual acuity assessment
• Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve Presence of idiopathic or autoimmune-associated uveitis
• Any intraocular surgery 3 months of entry
• Any prior thermal laser in the macula
• History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• Fondazione G.B. Bietti, IRCCS: collaborator
• University of Genova: collaborator
• University of Rome Tor Vergata: collaborator

Study Sites (3)

Massimo Nicolò

Genova, Italy

RECRUITING

Giuseppe Querques

Milan, 20134, Italy

RECRUITING

Mariacristina Parravano

Rome, Italy

RECRUITING

Related Publications (1)

• Querques G, Sacconi R, Gelormini F, Borrelli E, Prascina F, Zucchiatti I, Querques L, Bandello F. Subthreshold laser treatment for reticular pseudodrusen secondary to age-related macular degeneration. Sci Rep. 2021 Jan 26;11(1):2193. doi: 10.1038/s41598-021-81810-7.

  PMID: 33500505 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration, Age-Related, 2; Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Giuseppe Querques, MD, PhD

CONTACT

+390226434004; querques.giuseppe@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Retina & Imaging Unit, Clinical Professor, and Principal Investigator

Model Details: Prospective, randomized, longitudinal, interventional study

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: March 16, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

IT (3)