NCT04847635|RecruitingDMC
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
PASCAL-RPD
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PASCAL-RPD
Sponsor study identifier
interventional
50
1 country
3
Study Start
March 16, 2021
Actual (reported)Primary Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2021
Actual (reported)April 7, 2021
Actual (reported)April 19, 2021
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
Massimo Nicolò
Genova, Italy
Giuseppe Querques
Milan, 20134, Italy
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.
First Submitted
April 7, 2021
First Posted
April 19, 2021
Study Start
March 16, 2021
Actual (reported)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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Mariacristina Parravano
Rome, Italy
Primary Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 12, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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