Date: 2019-01-07
Type of information: Initiation of the trial
phase: registry
Announcement: initiation of the trial
Company: Gemini Therapeutics (USA)
Product:
Action mechanism:
Disease: dry Age-Related Macular Degeneration (AMD)
Therapeutic area: Ophthalmological diseases
Country:
Trial details: CLARITY will genetically screen and consent thousands of subjects, and will enroll hundreds based on genetic criteria. The screening process will assess dozens of genetic loci with coverage across all known high-risk genetic variants associated with dry AMD. Subjects will be separated into one of two studies: CLARITY1 is a prospective, multicenter, longitudinal registry, conducted in subjects with NC-GA secondary to dry AMD. Dozens of genetic loci will be assessed during the screening process providing coverage across all known high-risk genetic variants associated with dry AMD. Thousands of subjects will be genetically screened, and hundreds will be enrolled to CLARITY based on genetic criteria. Subjects in CLARITY1 will be followed for up to six years, contributing data every two years throughout the study unless they qualify for and agree to enter potential ongoing interventional studies for this program. Data will be collected on demographics, medical history, visual function testing, ophthalmic anatomic assessments, multi-modal ocular imaging, quality of life metrics and ocular fluid biomarkers. CLARITY2, a subset study of CLARITY1, is a prospective, multicenter, natural history study, conducted in subjects with NC-GA secondary to dry AMD. Hundreds of subjects who are carriers of rare and common CFH variants and associated complotypes will be followed in two parallel cohorts. Subjects will be followed for two years, contributing data every six months throughout the study unless they qualify for and agree to enter potential ongoing interventional studies for this program. Data will be collected on demographics, medical history, visual function testing, anatomic ocular assessments, multi-modal ocular imaging, quality of life metrics and ocular fluid biomarkers.
Latest news: • On January 7, 2019, Gemini Therapeutics, a product engine company focused on redefining dry AMD and linked disorders with precision medicine, announced the initiation of CLARITY, a disease registry and natural history study designed to 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. CLARITY will be used to inform and optimize the design of future interventional trials.
