Integration of Lesion-tailored, Fundus-controlled Perimetry Into Routine Clinical Care for Patients With Geographic Atrophy (GA) Receiving Pegcetacoplan Treatment in Accordance With the Approved Label.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border.
研究概览
简要总结
The goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. The study aims to determine whether lesion tailored fundus-controlled perimetry can reliably measure functional changes near areas of atrophy and whether this testing can be implemented in everyday clinic care over 24 months. Participants will undergo repeated vision testing, standard eye imaging, and visual function questionnaires while continuing their prescribed treatment.
详细描述
The study will prospectively recruit patients from the Retina Clinics at the John A. Moran Eye Center and its satellite clinics.
All team members will be trained and certified for their specific tasks to ensure that uniform procedures are followed in order to obtain comparable and reliable data.
The following study procedures will be performed after informed consent has been obtained (in chronologic order):
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Assessment of past and current ophthalmic history, and demographic details
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Best-corrected visual acuity (BCVA) for both eyes measured by Early Treatment Diabetic Retinopathy Study (ETDRS) or Snellen charts (performed at Visit [V]1, V2, V4 and V6)
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Fundus-controlled perimetry (FCP)
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Training Test (performed at V1, V2, V3, V4, V5, V6)
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Fixes macula pattern (performed at V1 and V6)
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Patient-tailored pattern (performed at V2 [twice for test - re-test assessment], V3, V4, V5, V6)
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Vision Impairment in Low Luminance with 33 items (VILL-33), a 33-item questionnaire (performed at V2, V4, and V6)
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Fundus autofluorescence (FAF), near infrared (NIR) and simultaneous spectral domain optical coherence tomography (SD-OCT) imaging (performed at V1, V4 and V6)
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Color digital fundus photographs (optional at visits V1, V4, and V6)
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OCT-angiography (OCT-A) imaging (optional at visits V1, V4 and V6)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65-90 years.
- •Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (AMD) in at least one eye with the following criteria:
- •GA lesion size between 1 and 15 mm² (≈ 0.4 to 6 disc areas)
- •GA borders must be at least 500 μm from the edge of the 30° × 25° optical coherence tomography (OCT) image frame
- •No confluent GA extending into peripapillary atrophy
- •Receiving intravitreal pegcetacoplan per label (at least one injection before screening).
- •Best-corrected visual acuity (BCVA) of 0.1 - 1.0 logMAR (≈ 20/20 to 20/200 Snellen)
- •Able to undergo mesopic FCP and required imaging.
- •Informed consent provided.
排除标准
- •Currently or previously active exudative macular neovascularization in the study eye.
- •High refractive errors (> ±5.00 Diopters [D] spherical equivalent) and significant astigmatism (> 2.50 D).
- •Ocular comorbidities likely to confound sensitivity or imaging (e.g., diabetic retinopathy with macular edema, retinal vein occlusion (RVO), inherited retinal disease, uncontrolled glaucoma).
- •Media opacity precluding reliable fundus-controlled perimetry (FCP) or imaging (e.g., dense cataract, corneal opacity, vitreous hemorrhage).
- •Any systemic condition judged likely to compromise participation, follow-up, or data integrity.
结局指标
主要结局
Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border.
时间窗: Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).
Quantify rates of mesopic sensitivity decline over time at defined distances from the Geographic Atrophy (GA) boundary.
次要结局
未报告次要终点
研究者
Monika Fleckenstein
Professor Ophthalmology and Visual Sciences
University of Utah