C3 Glomerulopathy (C3G) and Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Geographic Atrophy Risk Calculator Important Usage Information

Intended Use

•  This Geographic Atrophy (GA) Risk Calculator is only intended for disease state awareness and for use by an eye doctor to understand the factors for disease progression. This is not a diagnostic tool or a tool to assist in treatment selection.

•  All decisions about patient care and diagnosis shall be made by a patient’s physician using his or her independent clinical judgment.

•  The GA Risk Calculator predicts a potential 5-year risk of outcomes for a GA patient (time to severe visual impairment (Snellen 20/200) and time to subfoveal involvement). This tool was developed utilizing risk equations using retrospective electronic health records of GA data from Cleveland Clinic patients (n=410). Statistical tests identified the most prominent predictors for time to severe visual impairment prediction as baseline visual acuity, subfoveal lesion, age, sex, smoking, fellow eye GA and select comorbidities. Validation was conducted using the Sham arms of Oaks (ClinicalTrials.gov, NCT03525613) and Derby (NCT03525600) trials. There is no treatment-related data incorporated in the tool nor is this tool intended to make any treatment assessments or recommendations.

•  The risk calculator being presented is for illustrative purposes only. Patient disease experience and/or progression may vary and depends on many individual factors including, but not limited to, the patient’s clinical history.

Limitations

•  Patients enrolled in clinical trials are expected to differ from those seen in routine clinical practice on important risk factors, such as time from GA onset and other severity measures.

•  More frequent data collection during clinical trials (monthly) than routine practice (~quarterly) could impact estimates of time to event outcomes.

•  The risk calculator predicts 5-year outcomes. However, the rate of progression on these outcomes can change with time within those 5-years.

•  These calculated predictions do not guarantee onset of identified outcomes.

Proceed to GA Risk Calculator

Developed by Apellis Pharmaceuticals, Inc. in collaboration with The Cleveland Clinic Foundation