A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 37
- 主要终点
- Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
研究概览
简要总结
This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).
详细描述
Eligible participants will complete a 6-month Observation Phase, followed by a 24-month Treatment Phase, followed by an End of Study Visit. Eligible participants will be randomized at Month 6 in a 1:1 ratio to either ORACEA (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. Over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age >/=55 years
- •Best corrected visual acuity of 20/20 - 20/400 in the study eye
- •Best corrected visual acuity of hand motion or better in the non-study eye
- •Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye)
- •Geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas
排除标准
- •History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye
- •History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study
- •Prior treatment for non-exudative age-related macular degeneration
- •Current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition.
- •History of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
- •Any intraocular or periocular surgery within 90 days prior to Day 0 in the study eye.
- •History of any hypersensitivity to tetracycline components
- •Use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of Day 0
- •History of sensitivity to the sun
研究组 & 干预措施
ORACEA®
40mg doxycycline
干预措施: ORACEA® (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
时间窗: Month 6 and Month 30
次要结局
- Change in Best Corrected Visual Acuity (BCVA)(Month 6 and Month 30)
研究者
Paul Yates, MD, PhD
Associate Professor of Ophthalmology
University of Virginia