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

Primary Purpose

Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin 80mg
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Massachusetts Eye and Ear InfirmaryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intermediate Age-Related macular degeneration patients

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
December 23, 2020
Last Updated
October 7, 2021
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT04735263
Brief Title
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
Acronym
DELPHI
Official Title
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective interventional trial for off label use of FDA approved drug
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate Age-Related macular degeneration patients
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Other Intervention Name(s)
Lipitor 80 mg(Brand name)
Intervention Description
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 Measure Information:
Title
Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)
Description
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
Time Frame
18 Months
Title
Change in drusen volume measured by Spectral Domain OCT
Description
To measure and quantify improvement or positive response to high dose statin therapy in patients with intermediate AMD using drusen volume measured by SDOCT
Time Frame
18 months
Title
To correlate visual functions of dark adaption with change in drusen volume
Description
Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients
Description
Patient will have Best Corrected visual acuity, testing performed to check changes in vision function
Time Frame
18 months
Title
To correlate change in contrast sensitivity and retinal structural evaluation of study patients
Description
Patient will have quantitative contrast sensitivity function testing performed to check change in vision function with changes in drusen volume.
Time Frame
18 months
Title
To correlate change in microperimetry visual functional and retinal structural evaluation of study patients
Description
Patient will have microperimetry function testing performed to check change in this vision function with changes in drusen volume
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John B Miller, MD
Phone
617-573-3750
Email
John_miller@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deeba Husain
Phone
617-573-3750
Email
Deeba_Husain@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Miller, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John B Miller, MD
Phone
617-573-3750
Email
John_Miller@meei.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27077128
Citation
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.
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Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD

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