Clinical trial NCT02713204
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Regeneron Pharmaceuticals
Start date: 2016-03-31; Completion date: 2017-10-03
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

Detailed description:

Arms: arm 1: Participants were administered intravitreal injection of REGN910-3 (3 milligram \[mg\]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32. arm 2: Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32. arm 3: Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.
Interventions: intervention 1: REGN910-3 intervention 2: Intravitreal Aflibercept Injection (IAI)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
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6HH DSSHQGHG HOHFWURQLF VLJQDWXUH SDJH
6SRQVRU¶V 5HVSRQVLEOH &OLQLFDO 6WXG\ 7HDP /HDG
6HH DSSHQGHG HOHFWURQLF VLJQDWXUH SDJH
6SRQVRU¶V 5HVSRQVLEOH %LRVWDWLVWLFLDQ
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SAP_001.pdf: 


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