Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atorvastatin 80mg.
- Who it may be relevant to
- Registry conditions: Age-related Macular Degeneration. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Drug 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.
Primary outcome measures
- Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) [Time frame: 18 Months]
- Change in drusen volume measured by Spectral Domain OCT [Time frame: 18 months]
- To correlate visual functions of dark adaption with change in drusen volume [Time frame: 18 months]
Secondary outcome measures (3)
- To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients [Time frame: 18 months]
- To correlate change in contrast sensitivity and retinal structural evaluation of study patients [Time frame: 18 months]
- To correlate change in microperimetry visual functional and retinal structural evaluation of study patients [Time frame: 18 months]
Eligibility criteria
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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts Eye and Ear Infirmary — Boston
Publications
- 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
Identifiers
NCT: NCT04735263 · 2020P001265