NIGHT

Choroideremia // Clinical Trials // Inherited Retinal Degeneration // Kimberly Stepien // Ongoing // Sep 30 2020

Natural History of the Progression of Choroideremia Study (NIGHT)

  • Sponsor: NightstaRx, Ltd, a Biogen Company
  • Principal Investigator: Kimberly Stepien, MD
  • Study Coordinator: Nickie Stangel

Study objective:

To collect natural history data from a large cohort of male CHM patients to evaluate possible efficacy measures that could be utilized in future interventional trials of novel therapies.

Study design:

The study includes 8 study visits over a 20-month period. Study visits will involve ophthalmic evaluations/imaging.

Inclusion criteria:

  • Are male and ≥18 years of age
  • Have a clinical phenotype and confirmed genetic diagnosis of CHM
  • Have active disease clinically visible within the macular region
  • Have a BCVA better than or equal to 6/60 (20/200; decimal 0.1; LogMAR 1.0; 34-38 ETDRS letters) in at least one eye

Exclusion criteria:

  • Have a history of amblyopia in the eligible eye
  • Have participated in an interventional research study in the past 6 months

Contact Nickie Stangel with questions: 608-263-8783. For more information about this study: visit clinicaltrials.gov