Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Changes in the retinal sensitivity - 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in the retinal sensitivity - 12 months
时间窗: 12 months
Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 12 (unit of measure: dB)
Anatomical changes using structural optical coherence tomography (OCT)
时间窗: 12 months
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Rate of Progression
时间窗: 12 months
Rate of progression to advance AMD (GA and/or neovascular AMD)
次要结局
- Changes in the retinal sensitivity - 6 months(6 months)
- Anatomical changes using fundus autofluorescence (FAF)(12 months)
- Anatomical changes using OCT-angiography (OCT-A)(12 months)
- Genetic influence (% of AMD-associated single-nucleotide polymorphism (SNP) in treated patients)(12 months)
研究者
Querques Giuseppe
Head of Medical Retina & Imaging Unit, Clinical Professor, and Principal Investigator
Ospedale San Raffaele