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

San Donato Group (GSD)

Status: Enrolling

Conditions: Macular Degeneration, Dry; Macular Degeneration Intermediate; Laser Burn of Retina; Macular Degeneration, Senile

Treatments: Device: Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan); Device: Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)

Study type: Interventional

Funder types: Other

Identifiers

NCT04847635

PASCAL-RPD

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Subthreshold laser group

Experimental group

Description:

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

Treatment:

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

Sham group

Sham Comparator group

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.

Treatment:

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