Age-related Macular DegenerationPhase 2DELPHINCT04735263
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
A Phase 2 study testing Atorvastatin 80mg in people with Age-related Macular Degeneration, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Atorvastatin 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
John B Miller, MD, 617-573-3750, John_Miller@meei.harvard.edu
About this study
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
Read the 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).
- Conditions
- Age-related Macular Degeneration
- Being tested
- Atorvastatin 80mg
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
Also called Lipitor 80 mg(Brand name)
Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intermediate Age-Related macular degeneration patients | Other | 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 Receives: Drug: Atorvastatin 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 Months
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
Measured: 18 months
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.
Measured: 18 months
Secondary outcomes (3)
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
Measured: 18 months
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.
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start4 Feb 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional trial for off label use of FDA approved drug
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John B. Miller, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- John B Miller, MD, Principal investigator, Massachusetts Eye and Ear Infirmary, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735263
- Sponsor's protocol ID
- 2020P001265
- Acronym
- DELPHI
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27077128
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
- ClinicalTrials.gov ID
- NCT04735263
- Acronym / sponsor ID
- DELPHI / 2020P001265
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective interventional trial for off label use of FDA approved drug
| Arm | Type | Receives |
|---|---|---|
| Intermediate Age-Related macular degeneration patients | Other | Drug: Atorvastatin 80mgSubjects 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80mgAlso: Lipitor 80 mg(Brand name)Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study. | Drug | Intermediate Age-Related macular degeneration patients |
Primary outcome
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
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 27077128Vavvas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John B Miller, MD principal investigator
Massachusetts Eye and Ear Infirmary, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 80mg in people with Age-related Macular Degeneration, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John B Miller, MD (617-573-3750, John_miller@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) (time frame: 18 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.