A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate 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
- 30
- 试验地点
- 2
- 主要终点
- Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect.
By combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.
详细描述
*Objectives*
- The primary objective is to evaluate the safety of the reSEES treatment.
- The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD.
- Progression of intermediate AMD will be followed for one year,
- The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression.
*Other objectives*
- Evaluate the evolution of AMD-induced retinal morphological changes.
- Evaluate changes at the choriocapillaris vascular network and analyse/compare eventual transition to nAMD with natural history.
- Evaluate the effect of reSEES on retina functional parameters.
- Investigate the effect of reSEES on patients' perceived vision, mood, and general well-being.
- Evaluate the usability of the proposed laser console.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 50 years of age
- •Intermediate AMD, Grade AREDS 3
- •Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.
- •Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.
排除标准
- •Myopia > 8D
- •Maximum pupillary aperture ᴓ4mm with medical dilation
- •Anticipation of ocular surgery during the study
- •Clinically significative cataract
- •Ocular surgery 6 months or less before study entry
- •No previous retinal treatment, neither anti-VEGF (Anti-Vascular Endothelial Growth Factor ) therapy nor laser photocoagulation
- •Diabetic retinopathy
- •Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabetic macular oedema), retinal lesions, retinal vessel occlusions etc
- •Another obfuscating ocular disease including amblyopia, uncontrolled IOP (intraocular pressure), uncontrolled glaucoma or glaucomatous visual field loss, media opacity such as visually significant cataract, epiretinal membrane, vitreomacular traction, etc
- •Concomitant systemic diseases and factors affecting the study, as per investigator's discretion
- •Pregnant and lactating woman
- •Concomitant participation in another interventional clinical study
- •When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.
- •Photosensitivity
结局指标
主要结局
Treatment-Emergent Adverse Events (TEAE)
时间窗: From the first Treatment Session (T0), at each subsequent Treatment Sessions (T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Incidence, severity and time of AE
Absence of NIR-cSLO laser-light spot traces
时间窗: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Assessment of NIR-cSLO laser-light spot
Absence of autofluorescence (FAF) laser-light spot
时间窗: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Assessment of autofluorescence laser-light spot
次要结局
- Improvement in visual acuity(From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks))
- Progression of drusen cross-section (SD-OCT)(From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks))
- Progression to advanced AMD (SD-OCT)(From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks))