NCT05056025Unknown不适用
A PILOT STUDY TO EVALUATE THE PROGRESSION OF THE DISEASE AND RESPONSE TO SUPPLEMENTATION WITH POSTBIOTICS IGEN-0222 IN PATIENTS WITH MACULAR DEGENERATION
Institut de la Macula y la Retina2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Microperimetry
研究概览
简要总结
A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria:
- •>4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy).
- •1 area of cRORA + 2 > areas of iRORA. < 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.
排除标准
- •Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not ability to provide written informed consent. Not ability to return for all trial visits. if subject cannot attend all trial required visits. GA secondary to any condition other than specified. Any ocular condition in the study eye that would progress during the study that could affect central vision or otherwise be a confounding factor.
- •Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B.
- •Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).
- •Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year.
- •Any intraocular surgery or thermal laser within three (3) months of trial entry.
- •Any prior thermal laser in the macular region, regardless of indication. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
- •Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.
- •Pregnant or nursing women. Additionally, women with childbearing potential must be using at least two effective contraception methods.
结局指标
主要结局
Microperimetry
时间窗: 12 months
Median change difference in the % reduced threshold in microperimetry
Color vision change
时间窗: 12 months
Median change in red/green and yellow/blue color thresholds
次要结局
- Change in outer nuclear layer (ONL) volume(12 months)
- Best corrected visual acuity (BCVA)(12 months)
- incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci(12 months)
- complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci(12 months)
- Average Threshold microperimetry(12 months)
- Low luminance visual acuity (LLVA)(12 months)
- Advanced Vision and Optometric Test (AVOT)(12 months)
- Area of cumulative cRORA conversion(12 months)
- Rod and cone sensitivity(12 months)
- Change of drusen > 100 microns height(12 months)
- Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)(12 months)
- Change of SDD ribbon(12 months)
- Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion(12 months)
- Conversion to choroidal neovascularization (CNV)(12 months)
研究者
Jordi Mones MD PhD
Jordi Mones MD, PhD
Institut de la Macula y la Retina
研究点 (2)
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