A Phase I/II Randomized, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of SF0166 Topical Ophthalmic Solution in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 12
- 主要终点
- Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
研究概览
简要总结
The primary purpose of this study was to evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD).
详细描述
This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with Neovascular Age-related Macular Degeneration (AMD) were randomized to 1 of 2 treatment arms in a 1:1 ratio as follows: SF0166 low dose twice daily (BID) or SF0166 high dose BID.
Study subjects administered the randomly assigned treatment for 28 days. There was an additional 28-day post-treatment follow-up period. Study subjects returned for examination every 2 weeks for 8 weeks (2 months).
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
- •Male or female, 50 years of age or older.
- •Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) in the study eye that meet the following criteria:
- •Total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas
- •Choroidal neovascularization (CNV) >50% of lesion area
- •Intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT)
- •No atrophy or fibrosis involving the center of the fovea
- •Best-corrected Visual Acuity (BCVA) between 78 and 25 letters, inclusive, in the study eye at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD).
- •Treatment naïve (i.e., no previous anti--vascular endothelial growth factor [VEGF] treatment in the study eye) or previously treated study eye with adequate washout defined below:
- •Lucentis (ranibizumab): 30-day washout
- •Avastin (bevacizumab): 30-day washout
- •Eylea (aflibercept): 60-day washout
- •Macugen (pegaptanib): 45-day washout
- •Willing and able to return for all study visits.
- •Able to adhere to the study dosing requirements.
- •Understands and signs the written informed consent form.
排除标准
- •Non-study eye best corrected visual acuity (BCVA) worse than 20 letters at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
- •Choroidal neovascularization (CNV) in the study eye secondary to other causes (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis).
- •Previous macular laser photocoagulation or ocular photodynamic therapy in the study eye.
- •Media opacities or abnormalities in the study eye that would preclude visualization of the retina.
- •Other retinal pathologies in the study eye that would interfere with vision.
- •Retinal pigment epithelial (RPE) tear in the study eye.
- •Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined by optical coherence tomography (OCT) results.
- •Uncontrolled glaucoma or ocular hypertension in the study eye defined as an Intraocular Pressure (IOP) >25 millimeter of mercury (mmHg) regardless of concomitant treatment with IOP lowering medications.
- •Uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements (during the same visit) or diastolic >100 mmHg on optimal medical regimen
- •Previous pars plana vitrectomy in the study eye.
- •Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment.
- •Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1 month) prior to study enrollment.
- •Intravitreal/periocular/topical ocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment.
- •Concomitant use any topical ophthalmic medications in the study eye, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days (3 months) prior to study enrollment and expected to stay on stable dose throughout study participation. Artificial tears are allowed.
- •Chronic or recurrent uveitis in the study eye.
- •Ongoing ocular infection or inflammation in either eye.
- •A history of cataract surgery complicated by vitreous loss in the study eye.
- •Congenital eye malformations in the study eye.
- •A history of penetrating ocular trauma in the study eye.
- •Mentally handicapped.
- •Females of childbearing potential (i.e., who are not postmenopausal for at least 1 year or surgically sterile for at least 6 weeks prior to Visit 1 - Screening/Randomization) who are lactating, or who are pregnant as determined by a positive urine pregnancy test (UPT) at Visit 1 - Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, sexual abstinence, double barrier method, or vasectomized partner.
- •Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.
- •Contraindication to the study medications or fluorescein dye.
- •Other ocular pathologies that in the Investigator's opinion would interfere with vision in the study eye.
研究组 & 干预措施
SF0166 low dose BID
SF0166 low dose instilled in study eye BID for 28 days of treatment.
干预措施: SF0166 Topical Ophthalmic Solution (Drug)
SF0166 high dose BID
SF0166 high dose instilled in study eye BID for 28 days of treatment.
干预措施: SF0166 Topical Ophthalmic Solution (Drug)
结局指标
主要结局
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of erythema
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe)
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the optic nerve
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the fundus
Change in Intraocular Pressure From Baseline to Week 8
时间窗: Week 2, Week 4, Week 6 and Week 8
Mean and standard deviation of change from Baseline in intra-ocular pressure
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of bulbar conjunctival injection
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of edema
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with any lens opacity
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of hyphema
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the vitreous
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the retinal vessels
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
时间窗: Week 2, Week 4, Week 6 and Week 8
Results are mean plus standard deviation
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the macula/choroid
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with specified Cup:Disc ratio in the range from 0.1 to 0.9 with the higher number being worse
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
时间窗: Baseline and Week 4
Number and percentage of subjects with abnormal fluorescein angiogram findings
次要结局
- Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8(Week 2, Week 4, Week 6, and Week 8)