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

Age-related Macular Degeneration Clinical Trial

— DELPHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735263
• Other study ID #: 2020P001265
• Status: Recruiting
• Phase: Phase 2
• Start date: February 4, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2021
• Source: Massachusetts Eye and Ear Infirmary
• Contact: John B Miller, MD
• Phone: 617-573-3750
• Email: John_miller[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)	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	18 Months
Primary	Change in drusen volume measured by Spectral Domain OCT	To measure and quantify improvement or positive response to high dose statin therapy in patients with intermediate AMD using drusen volume measured by SDOCT	18 months
Primary	To correlate visual functions of dark adaption with change in drusen volume	Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.	18 months
Secondary	To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients	Patient will have Best Corrected visual acuity, testing performed to check changes in vision function	18 months
Secondary	To correlate change in contrast sensitivity and retinal structural evaluation of study patients	Patient will have quantitative contrast sensitivity function testing performed to check change in vision function with changes in drusen volume.	18 months
Secondary	To correlate change in microperimetry visual functional and retinal structural evaluation of study patients	Patient will have microperimetry function testing performed to check change in this vision function with changes in drusen volume	18 months