CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 557 enrolled
Drug / intervention
KSI-301 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04964089
NCT04964089Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Kodiak Sciences Inc·interventional·Posted Jul 15, 2021·Updated Jul 3, 2024

In Brief

A Phase 3 clinical trial evaluating KSI-301, Aflibercept, and 1 other intervention for Wet Age-related Macular Degeneration. Completed, enrolled 557 participants across 66 sites in 2 countries.

Detailed Summary

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWet Age-related Macular Degeneration
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 15, 2021
Enrollment StartJun 23, 2021
Primary CompletionMar 28, 2023
Study CompletionApr 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.0 years ago

Interventions

KSI-301drug

Intravitreal Injection

Afliberceptdrug

Intravitreal Injection

Sham Procedureother

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.