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

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ClinicalTrials.gov Identifier: NCT04735263
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
John B. Miller, MD, Massachusetts Eye and Ear Infirmary

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective 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 : February 4, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Intermediate Age-Related macular degeneration patients

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
 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 Name: Lipitor 80 mg(Brand name)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) [ Time Frame: 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

  2. Change in drusen volume measured by Spectral Domain OCT [ Time Frame: 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

  3. To correlate visual functions of dark adaption with change in drusen volume [ Time Frame: 18 months ]
    Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.


Secondary Outcome Measures :
  1. To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients [ Time Frame: 18 months ]
    Patient will have Best Corrected visual acuity, testing performed to check changes in vision function

  2. To correlate change in contrast sensitivity and retinal structural evaluation of study patients [ Time Frame: 18 months ]
    Patient will have quantitative contrast sensitivity function testing performed to check change in vision function with changes in drusen volume.

  3. To correlate change in microperimetry visual functional and retinal structural evaluation of study patients [ Time Frame: 18 months ]
    Patient will have microperimetry function testing performed to check change in this vision function with changes in drusen volume


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735263


Contacts
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Contact: John B Miller, MD 617-573-3750 John_miller@meei.harvard.edu
Contact: Deeba Husain 617-573-3750 Deeba_Husain@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: John B Miller, MD    617-573-3750    John_Miller@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: John B Miller, MD Massachusetts Eye and Ear Infirmary, Harvard Medical School
More Information
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Publications:

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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: February 3, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors