A Study to Evaluate the Safety and Efficacy of RQC for AMD

Korábbi kezelés

• Participation in another clinical study with an investigational product during the last 90 days.
• Previous retinal or other ocular surgical procedures (other than cataract extraction) that may have complicated assessment of the progression of AMD.
• Use of any anticoagulant medication within 5 days before the first dose of investigative product is scheduled or required for subsequent medical treatment in the course of the study.
• History of known allergy to any component of the investigational product.
• Preplanned surgery or procedures that would interfere with the conduct of the study.

Más betegség

• The presence of ocular disease or condition that may confound evaluation of the retina or could require medical or surgical intervention.
• A serious or complex systemic medical disease or condition with a poor five-year survival prognosis or that would make adherence or follow-up difficult or unlikely.
• Diagnosis of Alzheimer's disease or dementia, diagnosis of a serious gastrointestinal or stomach condition, or positive for HIV, hepatitis B surface antigen, or hepatitis C antibodies.
• History of inherited bleeding disorder.
• History of or a reason to believe participant has a history of drug or alcohol abuse within the past 5 years.

Laborértékek

• Clinically significant abnormal physical examination/vital signs or laboratory and coagulation blood tests as deemed appropriate by the investigator.

Egyéb

• The presence of wet AMD.
• Currently incarcerated prisoners.
• Currently pregnant or lactating.

• Male or female of any race or ethnicity.
• Aged 50-90 years at time of study entry.
• Ability to speak, read, and understand English.
• Ability to take oral medication and be willing to adhere to the study regimen.
• Capable of providing informed consent/provision of signed and dated informed consent.
• Stated willingness to comply with all procedures and availability for the duration of the study.
• Diagnosis of dry AMD (AREDS categories Early, drusen 63-124 µm in width; Intermediate, drusen ≥125 µm in width; or Advanced, macular geographic atrophy) as documented by OCT and/or color retinal photography.