Status:
UNKNOWN
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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 reducti...
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04735263
Start Date
February 4 2021
End Date
January 1 2024
Last Update
October 14 2021
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114