Osteoarthritis, Knee
Conditions
Keywords
Adeno-associated virus, Gene therapy, ICM-203, Osteoarthritis
Brief summary
This is an observational study of the long term safety and efficacy of ICM-203.
Detailed description
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.
Interventions
GENETICICM-203
Long term follow-up
DRUGPlacebo
Long term follow-up
Sponsors
ICM Co. Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Previous receipt of ICM-203 or matching placebo
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delayed adverse events | Up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain | Up to 3 years | Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable) |
| Knee function | Up to 3 years | Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems) |
| Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) | Up to 3 years | Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease |
| Joint space width | Up to 3 years | Evaluation of change from baseline in joint space width in mm as measured on knee radiograph |
| Incidence of total knee replacement | Up to 5 years | — |
Countries
Australia
Contacts
STUDY_DIRECTORAlison Heald, MD
ICM Co. Ltd.
Outcome results
None listed