Clinical Trials
NT501 Extension study in MacTel
A Phase 4, multicenter, open-label study to evaluate long-term safety and efficacy of Revakinagene Taroretcel-Lwey (NT-501) previously implanted during a Phase 1, Phase 2, or Phase 3 clinical study and to evaluate NT-501 implanted in participants who underwent the sham procedure in a Phase 3 clinical study of Macular Telangiectasia Type 2 (MacTel).
Overview
This research project is an extension study for those who previously participated in the Phase 1/2/3 NT-501 Implant study for people with macular telangiectasia type 2 (MacTel).
This research project will involve 2 arms – an observational and interventional arm.
The observational arm will involve conducting assessments on those who previously received the NT-501 implant in the earlier studies and will assess how well the implant holds up over time, and whether it remains effective and safe.
The observational arm will involve annual visits over a 5 year period.
The interventional arm will involve implantation of the NT-501 implant in the eye of those participants who underwent a sham procedure in the previous Phase 3 study.
For further information about this study please contact the Clinical Trials Research Centre on (03) 9929 8076 or email info@ceruleaclinicaltrials.org.au.
- Principal Investigator
Associate Professor Penelope Allen
This research project is an extension study for those who previously participated in the Phase 1/2/3 NT-501 Implant study for people with macular telangiectasia type 2 (MacTel).
This research project will involve 2 arms – an observational and interventional arm.
The observational arm will involve conducting assessments on those who previously received the NT-501 implant in the earlier studies and will assess how well the implant holds up over time, and whether it remains effective and safe.
The observational arm will involve annual visits over a 5 year period.
The interventional arm will involve implantation of the NT-501 implant in the eye of those participants who underwent a sham procedure in the previous Phase 3 study.
For further information about this study please contact the Clinical Trials Research Centre on (03) 9929 8076 or email info@ceruleaclinicaltrials.org.au.
- Principal Investigator