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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Changes in the retinal sensitivity - 12 months [Срок оценки: 12 months]
• Anatomical changes using structural optical coherence tomography (OCT) [Срок оценки: 12 months]
• Rate of Progression [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Changes in the retinal sensitivity - 6 months [Срок оценки: 6 months]
• Anatomical changes using fundus autofluorescence (FAF) [Срок оценки: 12 months]
• Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients) [Срок оценки: 12 months]
• Anatomical changes using OCT-angiography (OCT-A) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 3 центра

• Massimo Nicolò — Genova
• Giuseppe Querques — Milan
• Mariacristina Parravano — Rome

Публикации

• 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. PMID 33500505

Идентификаторы

NCT: NCT04847635 · PASCAL-RPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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