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Learn About Our Clinical Trials

To learn more details about our clinical studies or to inquire about how to participate, please contact us at (304) 346-4400.

  • Title: A decentralized epidemiological study of the progression of Age-related Macular Degeneration (AMD)

    Sponsor: Character Bio
    About the Study:
    The primary objective of the study is to generate a better understanding of the genetic contribution to variability and dynamic range of clinical progression from the earliest stages of drusen formation through to geographic atrophy (GA) and neovascular (nvAMD).

    AMD has a large genetic component; 34 common genetic variants have been discovered that are associated with AMD. A weighted polygenic risk score can classify an individualsʼ total level of genetic risk, and have some power to predict disease progression in combination with environmental and clinical risk factors.

    Individuals with high genetic risk but who donʼt progress to advanced disease may have protective genetic variants. This study will use genotyping and genome sequencing approaches to determine the level of genetic risk for each patient, and discover any protective variations they may have.

    This is an epidemiologic study; the risks of the assessments administered during the study are low, while there is benefit in the education about AMD the patients are receiving.

    Study Design: Epidemiologic study
    Study Duration: Approximately 15 years from when the study opens to enrollment.
    Study Participant Duration: Estimated 1 hour per visit for each individual subject

    Eligible participants
    You may be eligible if you have:

    1. Willingness and ability to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
    2. Male or female age 50 years or older at enrollment
    3. Retrospective clinical records documenting at least three (3) years of Age-related Macular Degeneration disease history and progression
    4. One eye with a current diagnosis of AMD consistent with any of the following ICD10 codes:
    • Nonexudative age-related macular degeneration, right eye
      o H35.3112 ...... intermediate dry stage
      o H35.3113 ...... advanced atrophic without subfoveal involvement
      o H35.3114 ...... advanced atrophic with subfoveal involvement
    • Nonexudative age-related macular degeneration, left eye
      o H35.3122 ...... intermediate dry stage
      o H35.3123 ...... advanced atrophic without subfoveal involvement
      o H35.3124 ...... advanced atrophic with subfoveal involvement
    • Nonexudative age-related macular degeneration, bilateral
      o H35.3132 ...... intermediate dry stage
      o H35.3133 ...... advanced atrophic without subfoveal involvement
      o H35.3134 ...... advanced atrophic with subfoveal involvement

    Ineligible participants
    You may be ineligible if:

    1. Individual does not have the legal ability make healthcare decisions on their own
    2. A current diagnosis with significant co-morbid condition that may preclude participation in research
    3. Current or active clinically significant neurological disorder (based on medical records and assessment of the Investigator)
    4. Use of investigational drugs or devices related to the treatment of eye-related disorders at any time previously
    5. Received gene/cell therapy at any time previously
    6. Other macular disease with subretinal deposits not typical of AMD, e.g. Central Serous Retinopathy (CSR) or Pachychoroid Pigment Epithelium (PPE)
    7. Concurrent diagnosis of proliferative diabetic retinopathy or visually significant macular edema with diabetic retinopathy
    8. Concurrent diagnosis of retinal vein occlusion, vitreomacular traction, macular hole, or any other retinal disease that may affect the patientʼs visual acuity and/or retinal thickness
    9. Any previous history of exudative (wet) AMD in the study eye(s) (the eye or eyes currently diagnosed with Dry AMD)
    10. Any previous history of anti-VEGF medications in the eye currently diagnosed with Dry AMD
    11. Use of any photobiomodulation light therapy (e.g., LumiThera Valeda system) with less than three years of patient history pre-treatment
    12. Any systemic or ocular medication known to be toxic to the retina, such as:
      Chloroquine/Hydroxychloroquine (Plaquenil) and Pentosan Polysulfate Sodium