NCT04049266

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 559 (actual)
• Sponsor: Kodiak Sciences Inc · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

Detailed description

This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.

Conditions

• Wet Macular Degeneration

Interventions

Type	Name	Description
DRUG	KSI-301	Intravitreal Injection
DRUG	Aflibercept	Intravitreal Injection
OTHER	Sham Procedure	The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Timeline

• Start date: 2019-10-08
• Primary completion: 2021-11-17
• Completion: 2022-04-26
• First posted: 2019-08-08
• Last updated: 2024-07-18
• Results posted: 2024-07-18

Locations

75 sites across 7 countries: United States, Czechia, Germany, Latvia, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study