NCT05409235已完成2 期
OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 68
- 主要终点
- Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
研究概览
简要总结
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
详细描述
This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) will be randomized 2:2:1:1 into the following groups: OTT166 5% twice daily (BID), OTT166 5% four times daily (QID), vehicle control BID, vehicle control QID. Randomization will be stratified by baseline Diabetic Retinopathy Severity Scale (DRSS) score (47 or 53 or 61B). Participants with PDR (DRSS score 61B) will be capped at 20% of all randomized participants. Each group will self-administer one 50-μl eye drop of study solution (frequency as assigned) for 24 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR [DRSS levels 47 or 53], or mild PDR [DRSS level 61] NVE < 0.5 DA in 1 + quadrants], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator
- •BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
- •Normal foveal contour
- •Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)
- •Willing and able to return for all study visits and comply with study-related procedures
- •Able to adhere to the study dosing requirements
- •Understands and signs the written Informed Consent Form
排除标准
- •CST of > 325 μm
- •a. Fluid in the central subfield is allowed so long as CST is ≤325 μm and there is a normal foveal contour as determined by the Central Reading Center
- •Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)
- •Eyes with DRSS score 61 with fibrous proliferations at disc or fibrous proliferations elsewhere a. DRSS score 61B with NVE only is allowed. Any sign of fibrosis proliferation is exclusionary
- •Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
- •Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed
- •Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
- •Uncontrolled glaucoma or ocular hypertension in the study eye defined as an IOP > 25 mmHg regardless of concomitant treatment with IOP-lowering medications
- •Hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic > 100 mmHg
- •Screening HbA1c blood test > 12.0%
- •Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications
- •Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months
- •Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined to be significant by the Investigator
- •Previous pars plana vitrectomy in the study eye
- •Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment
- •YAG laser treatment in the study eye within 90 days prior to study enrollment
- •Concomitant use of any topical ophthalmic medications in the study eye, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days prior to study enrollment and expected to stay on stable dose throughout study participation. Topical eyedrops are allowed but not within ±10 minutes of study drop application
- •Contact lens use from time of screening throughout the study
- •Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome
- •Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision (peripheral processes are not exclusionary)
- •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
- •Cognitive impairment that, in the opinion of the investigator, could compromise compliance with the requirements of the study
- •Females of childbearing potential (ie, 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 serum pregnancy test at Visit 1 -Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study a. Women who are breastfeeding or who have a positive serum hCG/urine pregnancy test at the screening or BL Visit
- •Females and males of childbearing potential unwilling or unable to utilize the following acceptable methods of birth control: tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, diaphragm or cervical cap with spermicide, or vasectomized partner for females; condoms with spermicidal agent and vasectomy for males; or sexual abstinence for males and females
- •Participation in any other investigational device or drug clinical research study within 12 weeks of Visit 1 - Screening/Randomization and during the duration of enrollment
- •Contraindication to the study medications or fluorescein dye
- •Other ocular pathologies that, in the investigator's opinion, would interfere with the participant's vision in the study eye
- •Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and OCT images in the study eye
- •Concomitant use of Semaglutide (Wegovy®, Ozempic®, Rybelsus®), Thiazolidinediones (Actos®, Avandia®), Liraglutides (Victoza®, Saxenda®), Dulaglutide (Trulicity®), or Tirzepatide (Mounjaro®) within 12 months prior to Visit 1 (allowed if a stable dose has been established for at least 1 year of use) a. Plans to start concomitant use of Semaglutide or Thiazolidinediones during the study duration is exclusionary
研究组 & 干预措施
OTT166 Cohort 1
Experimental
Participants will receive OTT166 5% twice a day (BID) for 24 weeks
干预措施: OTT166 (Drug)
OTT166 Cohort 2
Experimental
Participants will receive OTT166 5% four times a day (QID) for 24 weeks
干预措施: OTT166 (Drug)
Vehicle control Cohort 1
Placebo Comparator
Participants will receive vehicle control BID for 24 weeks
干预措施: Vehicle control (Drug)
Vehicle control Cohort 2
Placebo Comparator
Participants will receive vehicle control QID for 24 weeks
干预措施: Vehicle control (Drug)
结局指标
主要结局
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
时间窗: At week 24
To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.
次要结局
- Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)(At week 24)
- Proportion of Participants Who Developed CI-DME(At week 24)
- The Development of CI-DME(At week 24)
- Proportion of Participants With Lines Gained/Lost of BCVA(From Baseline (Day 1) up to Week 24)
- Change From Baseline in Central Subfield Thickness (CST)(From Baseline (Day 1) up to Week 24)
- Area Under The Curve (AUC) for Change From Baseline in CST(From Baseline (Day 1) up to Week 24)
- Proportion of Participants Who Met the Objective Rescue Criteria(From Baseline (Day 1) up to Week 24)
- Proportion That Met Objective Rescue Therapy Criteria by Week 24(From Baseline (Day 1) up to Week 24)
- Change From Baseline in Best Corrected Visual Acuity (BCVA)(From Baseline (Day 1) up to Week 24)
- Proportion of Participants Who Developed ASNV(At week 24)
- Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline(At week 24)
- Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC)(At Week 24)
- Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR(At week 24)
- Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)(At week 24)
- Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME(From Baseline (Day 1) up to Week 24)
- Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24(From Baseline (Day 1) up to Week 24)
- Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered(24 Weeks)
研究者
研究点 (68)
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