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)
Sponsored by
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
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).
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
No
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
Email
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
Email
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
Email
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
Email
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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