NCT04735263RecruitingPhase 2
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 23 Dec 2020
- Start date
- 4 Feb 2021
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Diseases
- Macular degeneration
- NCT number
- NCT04735263
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 21
- From 4 Feb 2021 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 concomitant use of cyclosporine
- 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
Other illness
- Patients with severe renal disease or multiple comorbidities
- Ocular infection;
Age
- Age \>85 years
Other
- Patients with known adverse reaction to statins
- Pregnancy
- Active uveitis;
- Any retinopathy other than AMD;
- Media opacities;
- Refractive error equal or superior to 6 diopters (spherical equivalent);
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts Eye and Ear Infirmary Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.