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

Phase 2

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: Atorvastatin 80mg

• Registration Number: NCT04735263
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-30
• Study First Posted: 2021-02-03
• Study Start: 2021-02-04
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-14
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermediate Age-Related macular degeneration patients	Atorvastatin 80mg	Subjects can have either: 1. Bilateral high-risk iAMD 2. High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm

Primary Outcome Measures

Name	Time	Method
Change in drusen volume measured by Spectral Domain OCT	18 months	To measure and quantify improvement or positive response to high dose statin therapy in patients with intermediate AMD using drusen volume measured by SDOCT
Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)	18 Months	Determine weather improvement in dark adaptation recovery time or rod intercept time (RIT) can be used as an early indicator of positive response to high dose statin therapy for intermediate AMD patients
To correlate visual functions of dark adaption with change in drusen volume	18 months	Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.

Secondary Outcome Measures

Name	Time	Method
To correlate change in microperimetry visual functional and retinal structural evaluation of study patients	18 months	Patient will have microperimetry function testing performed to check change in this vision function with changes in drusen volume
To correlate change in contrast sensitivity and retinal structural evaluation of study patients	18 months	Patient will have quantitative contrast sensitivity function testing performed to check change in vision function with changes in drusen volume.
To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients	18 months	Patient will have Best Corrected visual acuity, testing performed to check changes in vision function

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States