Macular Degeneration, SenilePASCAL-RPDNCT04847635
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
A study testing Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) in people with Macular Degeneration, Senile and Laser Burn of Retina, run by Ospedale San Raffaele at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Macular Degeneration, Senile, Laser Burn of Retina, Macular Degeneration Intermediate
- What is being tested?
- Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Mar 2021to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Massimo Nicolò
Genova
Massimo Nicolò, MD, +390103538469, massimonicolo@gmail.com
- Recruiting
Giuseppe Querques
Milan, 20134
Giuseppe Querques, MD, PhD, +390226434004, querques.giuseppe@hsr.it
Giuseppe Querques, MD, PhD
- Recruiting
Mariacristina Parravano
Rome
Mariacristina Parravano, +390685356727, mcparravano@gmail.com
About this study
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.
Read more
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
- Being tested
- Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan), Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)
- Keywords
- Retina, Age-related macular degeneration, Reticular pseudodrusen, Sub-threshold laser
- Medical subject headings
- Macular Degeneration, Age-Related, 2, Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Subthreshold laser group | Experimental | To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen. Receives: 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. Receives: Device: Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Anatomical changes using structural optical coherence tomography (OCT)
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Measured: 12 months
Rate of Progression
Rate of progression to advance AMD (GA and/or neovascular AMD)
Measured: 12 months
Secondary outcomes (4)
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)
Measured: 6 months
Anatomical changes using fundus autofluorescence (FAF)
Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF
Measured: 12 months
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).
Measured: 12 months
Anatomical changes using OCT-angiography (OCT-A)
Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Mar 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular Degeneration, SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, longitudinal, interventional study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione G.B. Bietti, IRCCS, University of Genova, University of Rome Tor Vergata
- Responsible party
- Principal investigator, Querques Giuseppe, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847635
- Sponsor's protocol ID
- PASCAL-RPD
- Acronym
- PASCAL-RPD
- Status last verified
- Mar 2025
- First submitted
- 7 Apr 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33500505
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04847635
- Acronym / sponsor ID
- PASCAL-RPD / PASCAL-RPD
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione G.B. Bietti, IRCCS, University of Genova, University of Rome Tor Vergata
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, longitudinal, interventional study
| Arm | Type | Receives |
|---|---|---|
| Subthreshold laser group | Experimental | Device: Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen. |
| Sham group | Sham comparator | Device: Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)The light from the retinal illumination system on the laser device will be used instead of the laser beam in all follow-up evaluations. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Subthreshold laser group |
| 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. | Device | Sham group |
Primary outcome
Changes in the retinal sensitivity - 12 months
Time frame: 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)
Time frame: 12 months
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Rate of Progression
Time frame: 12 months
Rate of progression to advance AMD (GA and/or neovascular AMD)
4 secondary outcomes
Changes in the retinal sensitivity - 6 months
Time frame: 6 months
Anatomical changes using fundus autofluorescence (FAF)
Time frame: 12 months
Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients)
Time frame: 12 months
Anatomical changes using OCT-angiography (OCT-A)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Background: PubMed 33500505Querques 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) in people with Macular Degeneration, Senile and Laser Burn of Retina, run by Ospedale San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Querques, MD, PhD (+390226434004, querques.giuseppe@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the retinal sensitivity - 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.