A Phase 3 Clinical Trial to Compare Efficacy, Safety, Tolerability and Immunogenicity of RBS-001 to Eylea® in Subjects with Neovascular Age-Related Macular Degeneration

Conditions

Neovascular age-related macular degeneration (nAMD)

Brief summary

Change from baseline (Day 1) in BCVA measured by ETDRS letter score at 8 weeks after the IP treatment

Detailed description

Change from baseline (Day 1) in BCVA measured by ETDRS letter score at all visits after the IP treatment will be analyzed using MMRM that includes the data from Weeks 4, 8, 12, 16, 20 and 24 after IP treatment, Change from baseline (Day 1) in BCVA measured by ETDRS letter score at each time point (within 52 weeks) after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score decreases by ≥ 5, ≥ 10 and ≥ 15 letters from baseline (Day 1) at all visits after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score increases by ≥5, ≥10 and ≥15 letters from baseline (Day 1) at all visits after the IP treatment, Change from baseline (Day 1) in CST measured by OCT at each time point (within 52 weeks) after the IP treatment, Proportion of subjects with intraretinal or subretinal fluid measured by OCT at each measurement time point after the IP treatment compared to baseline (Day 1), Change from screening in CNV area assessed by FA at 24 and 52 weeks after the IP treatment, Proportion of subjects having leakage assessed by FA at 24 and 52 weeks after the IP treatment compared to screening

Related papers

No related papers found yet.

Interventions

DRUGEylea 40 mg/mL solution for injection in a vial

DRUGFLUORESCEIN SODIUM

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline (Day 1) in BCVA measured by ETDRS letter score at 8 weeks after the IP treatment	—

Secondary

Measure	Time frame
Change from baseline (Day 1) in BCVA measured by ETDRS letter score at all visits after the IP treatment will be analyzed using MMRM that includes the data from Weeks 4, 8, 12, 16, 20 and 24 after IP treatment, Change from baseline (Day 1) in BCVA measured by ETDRS letter score at each time point (within 52 weeks) after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score decreases by ≥ 5, ≥ 10 and ≥ 15 letters from baseline (Day 1) at all visits after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score increases by ≥5, ≥10 and ≥15 letters from baseline (Day 1) at all visits after the IP treatment, Change from baseline (Day 1) in CST measured by OCT at each time point (within 52 weeks) after the IP treatment, Proportion of subjects with intraretinal or subretinal fluid measured by OCT at each measurement time point after the IP treatment compared to baseline (Day 1), Change from screening in CNV area assessed by FA at 24 and	—

Measure

Time frame

Change from baseline (Day 1) in BCVA measured by ETDRS letter score at all visits after the IP treatment will be analyzed using MMRM that includes the data from Weeks 4, 8, 12, 16, 20 and 24 after IP treatment, Change from baseline (Day 1) in BCVA measured by ETDRS letter score at each time point (within 52 weeks) after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score decreases by ≥ 5, ≥ 10 and ≥ 15 letters from baseline (Day 1) at all visits after the IP treatment, Proportion of subjects whose BCVA measured by ETDRS letter score increases by ≥5, ≥10 and ≥15 letters from baseline (Day 1) at all visits after the IP treatment, Change from baseline (Day 1) in CST measured by OCT at each time point (within 52 weeks) after the IP treatment, Proportion of subjects with intraretinal or subretinal fluid measured by OCT at each measurement time point after the IP treatment compared to baseline (Day 1), Change from screening in CNV area assessed by FA at 24 and

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Countries

Bulgaria, Croatia, Poland, Slovakia

Outcome results

None listed