Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT04735263
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin 80mg — DRUG
    Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.

Study Details

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

Key Dates

Start date
Feb 4, 2021
Status verified
Jan 2026
Primary completion
Apr 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Intermediate Age-Related macular degeneration patients
    Subjects can have either: 1. Bilateral high-risk iAMD 2. High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm

Primary Outcome Measure

Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) [ Time Frame: 18 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114
John B Miller, MD
[email protected]
617-573-3750

Find similar trials in Boston, MA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Massachusetts Eye and Ear Infirmary· Boston, MA

Related Studies