EUCTR2016-004601-14-HU进行中（未招募）1 期
A Randomized, Double Masked, Uncontrolled, Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants with Neovascular Age-Related Macular Degeneration (AMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. A treatment-naïve eye diagnosed with active, pathologic, newly diagnosed subfoveal and/or juxtafoveal with center involvement CNV lesions secondary to neovascular AMD (all lesion subtypes: older classifications include predominantly classic, minimally classic, or occult; newer classifications include Type 1 [sub RPE], Type 2 [subretinal], Type 3 [intra-retinal or mixed]) with the following characteristics:
- •active subfoveal leakage determined by FA;
- •total lesion area = 4 disc areas (i.e., = 10 mm2; 1 disc area = 2.54 mm2) determined by FA;
- •< 50% of total lesion area with blood;
- •< 25% of total lesion area comprised of fibrosis/scar and outside the fovea;
- •total area of CNV (including both classic and occult components) must comprise = 50% of the total lesion area; and
- •central point and/or central subfield retinal thickness = 300 microns, exclusive of any PEDs in the fovea, determined by SD-OCT.
- •2. Best-corrected ETDRS visual acuity in the study eye ranging between 68 and 39 letters, inclusive, (approximately equivalent to 20/50 to 20/160 Snellen). Study eye vision must meet this criterion at both Screening and Day 1 Visit. If the BCVA changes by 10 letters or more between the two visits, both an SD-OCT and FA must be taken at Day 1 and submitted to the IRC to ensure that the lesion still meets all study criteria prior to randomizing the participant to treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Lesion Characteristics-Study Eye
- •3. Significant serous PEDs will be excluded. PEDs will be considered significant if the PED is > 50% of the CNV lesion area or if it is > 400 microns in any diameter. Additional PED characteristics warranting exclusion include a contour that is irregular or corrugated, or evidence of an RPE tear. Borderline PEDs that cannot be clarified for significance after application of these criteria will be excluded if additional assessment by the IRC cannot clearly determine significance or insignificance.
- •5. The following in the macula: RAP, symptomatic vitreomacular adhesion (sVMA), retinal tear(s)/rip(s), or polypoidal polyps identified by FA and/or SD-OCT (confirmation by ICG angiography is not required). Non-ICG features of polypoidal polyps are well documented in the literature, and include but are not limited to nodular, orange-red RPE elevations observed during ophthalmoscopy, SD-OCT, and/or OCT angiography (OCT-A), neurosensory detachment, and subretinal lipid exudation and hemorrhage. In addition, typically FA evidence of leaking hyperfluorescence is present, which is most often an occult pattern of leakage.
- •7. Prior use (within the last 3 months) or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study in the opinion of the investigator.
研究者
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