Gemini Therapeutics has initiated CLARITY, a set of natural history studies that are designed to observe and help us better understand how specific genes affect the development of dry AMD. All patients who are screened for the CLARITY studies will be asked to consent for genetic testing that will identify the genetic profile specific to the nature of their disease. Data gained from Clarity will help to optimize the design of future interventional trials.
Identifying and Characterizing Disease Progression
The CLARITY studies identify and characterize disease progression in subjects with non-central geographic atrophy (NC-GA) secondary to dry AMD, who are carriers of high-risk genetic variants, through the analysis of the relationship between genotype, visual function, and disease progression by functional and structural ocular endpoints. The studies collect data on demographics, medical history, visual function testing, anatomic ocular assessments, multi-modal ocular imaging, quality of life metrics and ocular fluid biomarkers. CLARITY genetically screens and consents thousands of subjects and will enroll and follow hundreds over time, based on genetic criteria. Gemini has developed a custom genetic test which screens for dozens of genetic locations (loci) with coverage across all known high-risk genetic variants associated with dry AMD. Subjects who meet genetic variant requirements are invited to consent and undergo a screening assessment in order to determine eligibility into one of two studies: CLARITY 1 and 2.
CLARITY Study Design
CLARITY 1 is a genetic screening and disease registry which evaluates long-term clinical outcomes and disease progression in subjects who are carriers of functionally consequential genetic variants associated with AMD. Dozens of genetic loci are assessed during the screening process, providing coverage across all known high-risk genetic variants associated with dry AMD. Subjects are seen at 12 and 24 months and then every other year for up to 6 years.
CLARITY 2 is two-year prospective natural history study which evaluates the clinical characteristics and disease progression in subjects who are carriers of high-risk genetic variants in Complement Factor H (CFH). Subjects in CLARITY 2 are followed more closely for the first two years, being seen at 6, 12, 18, and 24 months, and then enter into the CLARITY 1 study for the remaining two visits at years 4 and 6.
CLARITY is the largest and most complete longitudinal prospective clinical study, to date, on subjects with high-risk genotypes in dry AMD. CLARITY aims to create a new paradigm of customized care for the diagnosis and treatment of dry AMD through a precision medicine approach. This changing paradigm has already been applied in diseases such as lung cancer and cystic fibrosis. As a result of precision medicine, patients with these diseases are now responding well to new targeted therapies. Our goal is to do the same for AMD by pioneering precision medicine in ophthalmology.