Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628947
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
A Phase II Study of Intravitreal KIO-301 in Patients with Late-stage Retinitis Pigmentosa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Randomised Controlled Double Masked Multiple Dose Study of the Safety Tolerability and Efficacy of Intravitreal KIO-301 in Patients with Late-stage Retinitis Pigmentosa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABACUS-2
Brief Summary:
The goal of the study is to investigate the safety tolerability and efficacy of up to 3 doses of KIO-301 administered by intravitreal IVT injection every 6 weeks in patients with late-stage RP
Late-stage RP patients will include those patients with No Light Perception NLP or Ultra-Low Vision ULV and Light Perception LP
Late-stage RP patients will include those patients with No Light Perception NLP or Ultra-Low Vision ULV and Light Perception LP
Detailed Description:
All enrolled and randomised study participants will attend study visits every 3 weeks during treatment 12 weeks and follow-up 12 weeks for PK safety amp tolerability and efficacy assessments The Screening period may be up to 45 days Total duration of the main study may be up to 30 weeks
For participants who received placebo in the main study and choose to participate in the OL extension duration of participation will be a further 24 weeks with total participation dependent upon time between completion of the main study and initiation of the OL extension
For participants who received placebo in the main study and choose to participate in the OL extension duration of participation will be a further 24 weeks with total participation dependent upon time between completion of the main study and initiation of the OL extension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None