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Monoclonal Antibodies

KSI-301 for Retinal Vein Occlusion (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
Signed informed consent prior to participation in the study.
Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 76
Awards & highlights

BEACON Trial Summary

This trial will compare the effectiveness of a new drug, KSI-301, to aflibercept in people with macular edema due to BRVO or CRVO.

Eligible Conditions
  • Retinal Vein Occlusion
  • Macular Edema

BEACON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BEACON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA.
Secondary outcome measures
Durability of KSI-301 5 mg compared to aflibercept 2 mg based on number of intravitreal injections during the study.
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA and CST.
Safety and Tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events.

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292
4%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment

BEACON 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

Find a Location

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor
7 Previous Clinical Trials
2,658 Total Patients Enrolled
1 Trials studying Retinal Vein Occlusion
121 Patients Enrolled for Retinal Vein Occlusion
Daniel Janer, MDStudy DirectorKodiak Sciences Inc
1 Previous Clinical Trials
253 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main conditions that KSI-301 is used to treat?

"KSI-301 is an effective medical intervention for treating wet age-related macular degeneration (wamd), macular edema, and diabetic macular edema (dme)."

Answered by AI

In how many different medical centers is this research project being conducted?

"There are 4 primary locations for this trial: Retina Associates of Western NY in Rochester, New york, Northwest Arkansas Retina Associates in Springdale, Arkansas, and Retina Consultants of San Diego in Poway, California. In addition, there are 99 other sites nationwide."

Answered by AI

Are there any available openings for new participants in this clinical trial?

"Unfortunately, this study is not currently enrolling patients. The listing for this trial was first posted on September 25th 2020 and updated as recently as July 20th 2022. There are 133 other trials related to branch vein occlusion that are still recruiting participants and 51 studies involving KSI-301."

Answered by AI

Can you provide more context on KSI-301 and its medical applications?

"KSI-301 was first studied in 2013 at the prestigious Massachusetts General Hospital. In the years since, there have been a total of 251 completed trials worldwide. As of now, 51 studies are actively recruiting patients; many of these trials are based in Rochester, New york."

Answered by AI

Has KSI-301 passed government regulation for public consumption?

"KSI-301 was given a safety rating of 3 by our team at Power. This is because KSI-301 is currently in Phase 3 clinical trials, which means that there is both some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

How many people will be included in this clinical trial?

"This study has already completed recruitment for participants. The trial first posted on September 25th, 2020 and was last updated on July 20th, 2022. However, there are 133 clinical trials actively searching for participants with branch vein occlusion and 51 studies for KSI-301 that are still recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~126 spots leftby Mar 2025