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

Sponsor

Massachusetts Eye and Ear Infirmary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04735263

Collaborator

(none)

Enrollment

Location

Arm

34.9

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Drug: Atorvastatin 80mg	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective interventional trial for off label use of FDA approved drugProspective interventional trial for off label use of FDA approved drug

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 4, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Intermediate Age-Related macular degeneration patients Subjects can have either: Bilateral high-risk iAMD High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm	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. Other Names: Lipitor 80 mg(Brand name)

Arm

Intervention/Treatment

Other: Intermediate Age-Related macular degeneration patients

Subjects can have either: Bilateral high-risk iAMD High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm

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.

Other Names:

Lipitor 80 mg(Brand name)

Outcome Measures

Primary Outcome Measures

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
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
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

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
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

Principal Investigator: John B Miller, MD, Massachusetts Eye and Ear Infirmary, Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

John B. Miller, MD, Assistant Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT04735263

Other Study ID Numbers:

2020P001265

First Posted:

Feb 3, 2021

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Macular Degeneration

Atorvastatin

Study Results

No Results Posted as of Oct 14, 2021