RecruitingNot ApplicableNCT04847635

Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration


Sponsor

Ospedale San Raffaele

Enrollment

50 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether subthreshold laser treatment — a form of laser therapy that is below the level that causes visible damage to the retina — can slow the progression of reticular pseudodrusen (RPD), a pattern of deposits under the retina that is associated with age-related macular degeneration (AMD). AMD is the leading cause of vision loss in older adults, and RPD carries a high risk of progression to more advanced disease. Current treatments for AMD do not specifically target RPD. Participants will receive the subthreshold laser treatment to one eye and be followed over time with imaging and vision testing to see whether the treatment slows disease progression compared to an untreated eye. You may be eligible if: - You are 50 years or older (55+ per study protocol) - You have reticular pseudodrusen secondary to AMD - Your best-corrected vision is between 20/20 and 20/400 - You have clear ocular media (no cataracts or vitreous bleeding obstructing the view) - You can provide consent and attend follow-up visits You may NOT be eligible if: - You have geographic atrophy or choroidal neovascularization (wet AMD) - You have had prior AMD treatments (other than antioxidants) - You have had prior thermal laser treatment to the macula or vitrectomy - You are a woman of childbearing potential not using highly effective contraception - You have participated in another investigational drug study within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPascal 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.

DEVICEPascal 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.


Locations(3)

Massimo Nicolò

Genova, Italy

Giuseppe Querques

Milan, Italy

Mariacristina Parravano

Rome, Italy

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NCT04847635


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