An interventional study of Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan) and Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan) in Macular Degeneration, Senile, Laser Burn of Retina and Macular Degeneration Intermediate, sponsored by Ospedale San Raffaele. Recruiting at 3 sites in Italy. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Ospedale San Raffaele · Not applicable, Interventional, and Treatment
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.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 141 interventional studies indexed under Geographic Atrophy.
Browse Geographic Atrophy studies →Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To evaluate the efficacy of Subthreshold laser in the treatment of reticular pseudodrusen.
Device: Pascal Synthesis 577 sub-threshold laser (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.
Device: Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)
The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.
The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.
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)
Time frame: 12 months
Anatomical changes using structural optical coherence tomography (OCT)
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Time frame: 12 months
Rate of Progression
Rate of progression to advance AMD (GA and/or neovascular AMD)
Time frame: 12 months
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)
Time frame: 6 months
Anatomical changes using fundus autofluorescence (FAF)
Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF
Time frame: 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).
Time frame: 12 months
Anatomical changes using OCT-angiography (OCT-A)
Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A
Time frame: 12 months
Plan to share: Undecided
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