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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    21
  • sponsor
    Massachusetts Eye and Ear Infirmary
Updated on 22 October 2021
drusen
spectral domain optical coherence tomography

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 reduction measured by SD-OCT

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 the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable).

Details
Condition Macular Degeneration, age-related macular degeneration
Treatment Atorvastatin 80mg
Clinical Study IdentifierNCT04735263
SponsorMassachusetts Eye and Ear Infirmary
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note