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Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration (PASCAL-RPD)

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Macular Degeneration, Senile focused on measuring Retina, Age-related macular degeneration, Reticular pseudodrusen, Sub-threshold laser

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Previous therapeutic radiation in the ocular region in either eye
Any treatment with an investigational agent in the previous 60 days before study entry
Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization (further definition can be found in Section 12.7) at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment.
Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline [Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary

Sites / Locations

Massimo NicolòRecruiting
Giuseppe QuerquesRecruiting
Mariacristina ParravanoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Subthreshold laser group

Sham group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Anatomical changes using structural optical coherence tomography (OCT)

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

Rate of Progression

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

Secondary Outcome Measures

Changes in the retinal sensitivity - 6 months

Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 6 (unit of measure: dB)

Anatomical changes using fundus autofluorescence (FAF)

Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF

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

The % of AMD-associated single-nucleotide polymorphism (SNP) will be evaluated analyzing the % of patients with an AMD-associated SNP in patients showing no progression vs progression to advance AMD (main outcome 3).

Anatomical changes using OCT-angiography (OCT-A)

Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A

Full Information

NCT ID

NCT04847635

First Posted

April 7, 2021

Last Updated

August 31, 2023

Sponsor

Ospedale San Raffaele

Collaborators

Fondazione G.B. Bietti, IRCCS, University of Genova, University of Rome Tor Vergata

1. Study Identification

Unique Protocol Identification Number

NCT04847635

Brief Title

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

Acronym

PASCAL-RPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 16, 2021 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ospedale San Raffaele

Collaborators

Fondazione G.B. Bietti, IRCCS, University of Genova, University of Rome Tor Vergata

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, randomized, longitudinal, interventional study

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subthreshold laser group

Arm Type

Experimental

Arm Description

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

Arm Title

Sham group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in the retinal sensitivity - 12 months

Description

Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 12 (unit of measure: dB)

Time Frame

12 months

Title

Anatomical changes using structural optical coherence tomography (OCT)

Description

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

Time Frame

12 months

Title

Rate of Progression

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Changes in the retinal sensitivity - 6 months

Description

Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 6 (unit of measure: dB)

Time Frame

6 months

Title

Anatomical changes using fundus autofluorescence (FAF)

Description

Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF

Time Frame

12 months

Title

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

Description

Time Frame

12 months

Title

Anatomical changes using OCT-angiography (OCT-A)

Description

Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Previous therapeutic radiation in the ocular region in either eye Any treatment with an investigational agent in the previous 60 days before study entry Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization (further definition can be found in Section 12.7) at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment. Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline [Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giuseppe Querques, MD, PhD

Phone

+390226434004

querques.giuseppe@hsr.it

Facility Information:

Facility Name

Massimo Nicolò

City

Genova

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Massimo Nicolò, MD

Phone

+390103538469

massimonicolo@gmail.com

Facility Name

Giuseppe Querques

City

Milan

ZIP/Postal Code

20134

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Querques, MD, PhD

Phone

+390226434004

querques.giuseppe@hsr.it

First Name & Middle Initial & Last Name & Degree

Giuseppe Querques, MD, PhD

First Name & Middle Initial & Last Name & Degree

Riccardo Sacconi, MD, FEBO

First Name & Middle Initial & Last Name & Degree

Enrico Borrelli, MD, FEBO

Facility Name

Mariacristina Parravano

City

Rome

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariacristina Parravano

Phone

+390685356727

mcparravano@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33500505

Citation

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.

Results Reference

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

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