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New treatment option for Age-related Macular Degeneration
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 80mg?
Atorvastatin 80mg is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for age-related macular degeneration.
Also referred to as Lipitor 80 mg(Brand name).
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
- 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
- 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...
- people 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.
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
- people 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.
- 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's taking place
- 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 - 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?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.