Regression of Some High-risk Features of Age-related Macular Degeneration (AMD) in Patients Receiving Intensive Statin Treatment.
Demetrios G Vavvas, Anthony B Daniels, Zoi G Kapsala...
https://pubmed.ncbi.nlm.nih.gov/27077128Actively Recruiting
Phase 2
Age: 50Years - 85Years
All Genders
ID04735263
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate Age-Related Macular Degeneration
Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-01-26
21
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of high-dose atorvastatin (80 mg) in patients with intermediate age-related macular degeneration (AMD) to see if it can improve dark adaptation recovery time and reduce drusen volume in the eye. This phase 2 interventional trial aims to correlate how well patients recover their vision in low light with changes in drusen, which are deposits that can block nutrient flow and worsen AMD. The study seeks to provide early indications of treatment response to help guide care decisions, especially when considering side effects or alternative treatments. Participants will receive 80 mg of atorvastatin daily if they tolerate it throughout the study. Eligible patients have either bilateral high-risk intermediate AMD or high-risk intermediate AMD in one eye with geographic atrophy (GA) or choroidal neovascularization (CNV) in the other eye. There is no control group in this trial. The treatment and observations will continue over an 18-month period. During the study, participants will have their dark adaptation recovery time measured by rod intercept time and drusen volume assessed using spectral domain optical coherence tomography (SD-OCT). Additional evaluations will include best corrected visual acuity, contrast sensitivity, and microperimetry to assess visual function and retinal structure. These assessments will occur throughout the 18 months to monitor changes and safety under medical supervision.
CONDITIONS
Brief Title
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
Who Can Participate
Age: 50Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults with intermediate AMD diagnosis in one or both eyes
- High-risk intermediate AMD in the study eye defined by numerous large, confluent drusen covering at least 0.5 disk area, with or without pigmentary changes, but no geographic atrophy or choroidal neovascularization
- Participants may have either bilateral high-risk intermediate AMD or high-risk intermediate AMD in one eye with geographic atrophy and/or choroidal neovascularization in the other eye
You will not qualify if you...
- Previous use of high-dose atorvastatin (80 mg)
- Previous use of other statins when primary care provider deems high-dose atorvastatin unsafe or contraindicated
- Known adverse reaction to statins
- Severe kidney disease or multiple other health conditions
- Age over 85 years
- Pregnancy
- Use of cyclosporine
- Active uveitis or ocular infection
- Any retinopathy other than AMD
- Media opacities affecting vision
- Refractive error equal to or greater than 6 diopters
- Prior retina surgery
- Other ocular surgery or intraocular procedures in the study eye within 90 days before enrollment, except anti-angiogenic injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 18 months
Participants receive 80mg of Atorvastatin daily, if they are able to tolerate it, from the start to the end of the study.
Regular visits to monitor response and safety throughout treatment
Trial Site Locations
Total: 1 location
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Actively Recruiting
Loading map...
Research Team
J
John B Miller, MD
D
Deeba Husain
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here