Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD

Обзор

interventional trial for off label use of high dose atorvastatin 80 mg in intermediate AMD patients and correlate recovery response measured by dark adaptation recovery time with drusen volume reduction measured by SD-OCT

Подробное описание

Dark adaptation recovery time is a sensitive marker of AMD progression in intermediate AMD, largely owing to drusen volume providing a transport barrier that slows the transfer of nutrients between the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable).

Вмешательства

• Препарат Atorvastatin 80mg
  Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.

Первичные конечные точки

• Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) [Срок оценки: 18 Months]
• Change in drusen volume measured by Spectral Domain OCT [Срок оценки: 18 months]
• To correlate visual functions of dark adaption with change in drusen volume [Срок оценки: 18 months]

Вторичные конечные точки (3)

• To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients [Срок оценки: 18 months]
• To correlate change in contrast sensitivity and retinal structural evaluation of study patients [Срок оценки: 18 months]
• To correlate change in microperimetry visual functional and retinal structural evaluation of study patients [Срок оценки: 18 months]

Критерии участия

Критерии включения

• All subjects with intermediate AMD diagnosis in one or both eyes will be considered, regardless the severity stage and subtype of disease in the other eye.

High-risk iAMD (numerous large, confluent drusen covering ≥ 0.5 disk area, with or without pigmentary changes but having no evidence of GA or CNV) in the study eye

Subjects can have either:

(i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.

Критерии исключения

• Patient previously taking high dose Atorvastatin 80 mg
• Patients previously taking other statins than high dose atorvastatin, in whom primary care provider (PCP) feels cannot be safely moved to high dose atorvastatin or those in which high dose atorvastatin is deemed contraindicated by PCP
• Patients with known adverse reaction to statins
• Patients with severe renal disease or multiple comorbidities
• Age >85 years
• Pregnancy
• Patients with concomitant use of cyclosporine
• Active uveitis;
• Ocular infection;
• Any retinopathy other than AMD;
• Media opacities;
• Refractive error equal or superior to 6 diopters (spherical equivalent);
• Any previous retina surgery;
• Other ocular surgery or intra-ocular procedure in the study eye (injection other than anti angiogenic injection, laser) within the 90 days prior to enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts Eye and Ear Infirmary — Boston

Публикации

• Vavvas DG, Daniels AB, Kapsala ZG, Goldfarb JW, Ganotakis E, Loewenstein JI, Young LH, Gragoudas ES, Eliott D, Kim IK, Tsilimbaris MK, Miller JW. Regression of Some High-risk Features of Age-related Macular Degeneration (AMD) in Patients Receiving Intensive Statin Treatment. EBioMedicine. 2016 Feb 4;5:198-203. doi: 10.1016/j.ebiom.2016.01.033. eCollection 2016 Mar. PMID 27077128

Идентификаторы

NCT: NCT04735263 · 2020P001265

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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