Leber congenital amaurosis (LCA)
Conditions
Brief summary
Change from baseline in best-corrected visual acuity (BCVA) based on the Freiburg Acuity and Contrast Test (FrACT) between treatment eyes (TEs) and placebo control eyes (PCEs) at 12 months.
Detailed description
Change from baseline in low luminance visual acuity (LLVA) based on FrACT between TEs and PCEs at 12 months., Change from baseline in retinal sensitivity as measured by dark-adapted full-field stimulus test (FST) between TEs and PCEs at 12 months., Eye-specific Patient Global Impression of Change (PGI-C) between TEs and PCEs at 12 months., Change from baseline in contrast sensitivity (CS) between TEs and PCEs based on quick contrast sensitivity function (qCSF) at 12 months., Incidence and severity of ocular and non-ocular adverse events (AEs).
Interventions
DRUGPlacebo
Sponsors
Laboratoires Thea
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) based on the Freiburg Acuity and Contrast Test (FrACT) between treatment eyes (TEs) and placebo control eyes (PCEs) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in low luminance visual acuity (LLVA) based on FrACT between TEs and PCEs at 12 months., Change from baseline in retinal sensitivity as measured by dark-adapted full-field stimulus test (FST) between TEs and PCEs at 12 months., Eye-specific Patient Global Impression of Change (PGI-C) between TEs and PCEs at 12 months., Change from baseline in contrast sensitivity (CS) between TEs and PCEs based on quick contrast sensitivity function (qCSF) at 12 months., Incidence and severity of ocular and non-ocular adverse events (AEs). | — |
Countries
Belgium, France, Germany, Netherlands
Outcome results
None listed