ABACUS-2 Study (Protocol number: KIO-301-2101)
This study that will investigate the safety, tolerability and efficacy of up to 3 doses of KIO-301 administered by intravitreal (IVT) injection into both eyes every 6 weeks in patients with late-stage retinitis pigmentosa (RP).
Late-stage RP patients can include those patients with No Light Perception (NLP), or Low Vision (LV).
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, 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 open label (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.
ClinicalTrials.gov Identifier: NCT06628947
Principal Investigator: Dr Chen, Fred
For further information about this study, you may visit Clinical Trial Registry:
https://clinicaltrials.gov/ct2/show/NCT03683251?term=velodrome&draw=1&rank=2
Or contact the Lions Eye Institute Clinical Trials Office telephone (08) 9381 0750 or email clinicalresearch@lei.org.au.
