Age-related Macular Degeneration study: Atorvastatin
Official title Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
ClinicalTrials.gov ID: NCT04735263
What this study is testing
What is Atorvastatin 80 mg?
An investigational high‑dose statin being studied for age‑related macular degeneration. It is designed to lower cholesterol levels in the blood.
Also referred to as Lipitor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether a high dose of the cholesterol drug atorvastatin can improve eye health in people with intermediate AMD, and whether changes in how quickly the eye adapts to darkness match changes in eye tissue seen on imaging.
- Who it's for
- Adults with intermediate age‑related macular degeneration.
- What's involved
- Participants will take 80 mg of atorvastatin daily and will have eye tests that measure how quickly their vision adapts to darkness and scans that show the amount of drusen (tiny deposits) in the eye.
- Time commitment
- The study lasts several months, with regular clinic visits for medication monitoring and eye testing.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- All people with intermediate AMD diagnosis in one or both eyes will be considered, regardless the severity stage and subtype of disease in the other...
- 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...
- (i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
You likely can't join if
- 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...
- Patients with known adverse reaction to statins
- Patients with severe renal disease or multiple comorbidities
- Age \>85 years
- Pregnancy
See the full eligibility criteria
- All people 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
- (i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.