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Monoclonal Antibodies

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (BEACON Trial)

Phase 3

Waitlist Available

Research Sponsored by Kodiak Sciences Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 - week 48

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests KSI-301, an eye injection, in people with vision problems from eye swelling due to vein blockages. The drug aims to reduce swelling and improve vision.

Eligible Conditions

Retinal Vein Occlusion
Cystoid Macular Edema
Central Retinal Vein Occlusion
Macular Edema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 - week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients.

Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants.

Secondary study objectives

Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants.

Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants.

Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants.

+5 more

Side effects data

From 2023 Phase 3 trial • 568 Patients • NCT04592419

11%

COVID-19

11%

Hypertension

Conjunctival haemorrhage

Conjunctival haemorrhage - Study eye

Retinal Vein Occlusion

Urinary tract infection

Retinal detachment

Atrial fibrillation

Acute myocardial infarction

Haemorrhagic stroke

100%

80%

60%

40%

20%

Study treatment Arm

KSI-301 (Arm A)

Aflibercept (Arm B)

KSI-301 5mg Extension Phase

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KSI-301 (Arm A)Experimental Treatment2 Interventions

Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria.

Group II: Aflibercept (Arm B)Active Control2 Interventions

Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KSI-301

2020

Completed Phase 3

~1130

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