A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX 314 Gene Therapy in Participants with nAMD (ASCENT)

Research summary

This phase 3, partially masked, randomized, multicenter study will include 2 periods: an Active Run-in Period (ie, Screening) and an Assessment Period. Participants who receive ABBV-RGX-314 will be strongly encouraged to enroll into a long-term follow-up (LTFU) study (RGX-314-5101) after completion of or early discontinuation from this current study and will sign a separate informed consent for the LTFU study at that time. The Active Run-in Period, which will last up to 6 weeks, will begin when the participant signs the informed consent form (ICF) and will end once the participant has been evaluated for eligibility, has received an intravitreal injection of ranibizumab 0.5 mg (at Screening Visit 1 [Week 6]), has been evaluated for an anatomic response to ranibizumab (at Screening Visit 2 [Week 5]) and has received an intravitreal injection of 2 mg aflibercept (at Randomization Visit [Week 2]). The Assessment Period will begin after randomization and will last up to 1 year (Week 54) or, for the aflibercept control arm participants who cross over to ABBV-RGX-314 treatment after Week 54, will last up to an additional year (Week 108).

Principal Investigator

Prof Dominik Fischer

Contact us

Email: ERGO@ouh.nhs.uk

IRAS number

1008138