试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- 12-month survival using Step 1 of assigned therapy
研究概览
简要总结
The AGLT is a prospective, multicenter, randomized study in which adult black Africans with treatment-naive open-angle glaucoma are assigned to therapy with selective laser trabeculoplasty (SLT), medications provided at no cost (MED), or medications provided by prescription for subjects to obtain at their own expense as per usual care (RX). The overall goal of the AGLT is to determine the best treatment strategy for newly-diagnosed open-angle glaucoma in Africa.
详细描述
This study is designed to test the hypothesis that the efficacy of SLT is non-inferior to medical therapy and the effectiveness of SLT is superior to medical therapy for glaucoma. This is a prospective, multicenter, active-controlled, parallel-group randomized trial. One eye per subject is included in this study and is randomized 1:1:1 to one of three treatment arms:
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SLT arm (provided at no cost)
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Step 1: Initial 360 degree SLT
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Step 2: Repeat 360 degree SLT
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MED arm (provided at no cost)
-
Step 1: Latanoprost 0.005% once daily
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Step 2: Adjunctive timolol 0.5% twice daily
-
RX arm (Usual Care- dispensed by prescription to be obtained at subjects' expense)
-
Step 1: Prescription for latanoprost 0.005% once daily
-
Step 2: Prescription for adjunctive timolol 0.5% twice daily
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
- Single (Outcomes Assessor)
盲法说明
Study personnel assessing IOP will be masked to treatment assignment during the first 12-month period and to all prior IOP measurements at every visit. IOP will be obtained using the iCare tonometer which provides an objective, digital reading.
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female black African aged 18 years or older
- •Diagnosed with
- •early or moderate open-angle glaucoma in one or both eyes (cup-disc ratio (CDR) < 0.9 and (if available) no glaucoma-related visual field loss in the central 10° on automated perimetry; or,
- •if diagnosed with advanced glaucoma (CDR > 0.9 or glaucoma-related visual field loss within the central 10° on automated perimetry), meet at least one of the following criteria:
- •i. Surgery is not available in the region of the study site; or ii. The subject is deemed not to be a candidate for surgery in the investigator's judgment; or iii. Surgery was offered and refused with no knowledge of this study.
- •Treatment-naïve: no prior treatment for open-angle glaucoma (including medications, laser, or glaucoma surgery) in both eyes
- •Untreated intraocular pressure >18 mmHg and <32 mmHg in the study eye at both baseline visits
- •Best-corrected visual acuity no worse than 20/400 in the study eye measured using Snellen's chart
- •Open iridocorneal angle (Shaffer Grade 3 or 4) with no more than 3 clock hours of peripheral anterior synechiae in both eyes
- •No contraindications to any of the study interventions
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
排除标准
- •Any glaucoma diagnosis other than open-angle glaucoma
- •Advanced stage glaucoma, defined as CDR > 0.9 or visual field loss within the central 10° on automated perimetry attributable to glaucoma (in the investigator's judgment)
- •The rationale for excluding subjects with advanced glaucoma is that these subjects would typically undergo surgery rather than laser or medical treatment. However, subjects with advanced stage glaucoma can be enrolled if any of the following three conditions are met:
- •Surgery is not available in the region of the study site; or
- •The subject is deemed not to be a candidate for surgery in the investigator's judgment; or
- •Surgery was offered and refused with no knowledge of this study In these cases, the subject would not undergo surgery regardless of participation in the study, and therefore should not be prevented from participation on this basis alone.
- •Currently or previously under treatment for glaucoma using medications, laser therapy or surgical interventions
- •Any corneal pathology that would preclude accurate assessment of IOP by rebound tonometry
- •Any non-glaucoma intraocular surgical procedure within the past 6 months
- •Contraindications to any of the study interventions
- •For SLT: no known absolute contraindications
- •For latanoprost: known hypersensitivity to any product ingredients
- •For timolol: bronchial asthma or history of such; severe chronic obstructive pulmonary disease; sinus bradycardia (<55 beats per minute); second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any product ingredients
- •Pregnancy or lactation
- •Inability to attend all scheduled study visits
研究组 & 干预措施
SLT
The study eye will undergo 360-degree selective laser trabeculoplasty (SLT), followed, if needed, by repeat 360-degree SLT.
干预措施: Selective laser trabeculoplasty (SLT) (Procedure)
MED
The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided at no cost to the subject.
干预措施: Latanoprost ophthalmic solution (Drug)
MED
The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided at no cost to the subject.
干预措施: Timolol ophthalmic solution (Drug)
RX
The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided by prescription to be obtained at the subject's expense. This represents usual care for glaucoma in Africa and other regions of the world.
干预措施: Latanoprost ophthalmic solution (Drug)
RX
The study eye will receive latanoprost ophthalmic solution 0.005% once daily, followed, if needed, by adjunctive timolol ophthalmic solution 0.5% twice daily. Medications will be provided by prescription to be obtained at the subject's expense. This represents usual care for glaucoma in Africa and other regions of the world.
干预措施: Timolol ophthalmic solution (Drug)
结局指标
主要结局
12-month survival using Step 1 of assigned therapy
时间窗: Month 12
The proportion of eyes in each treatment group that achieve and maintain target IOP (minimum 20% reduction from baseline and IOP \< 22 mmHg) through Month 12 using only Step 1 of therapy
次要结局
- Nature and incidence of treatment-emergent adverse events(Month 12)
- Clinical utility of repeat SLT(Month 36)
- 12-month survival using Step 1 +/- Step 2 of assigned therapy(Month 12)
研究者
Anthony Realini
Professor of Ophthalmology
West Virginia University