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Monoclonal Antibodies

KSI-301 for Age-Related Macular Degeneration (DAYLIGHT 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 to week 52
Awards & highlights

DAYLIGHT Trial Summary

This trial will compare the effectiveness and safety of a new drug, KSI-301, to aflibercept for treating wet age-related macular degeneration.

Eligible Conditions
  • Wet Age-related Macular Degeneration

DAYLIGHT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 52 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
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on OCT-CST
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA
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

DAYLIGHT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KSI-301 (Treatment Group A)Experimental Treatment1 Intervention
Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
Group II: Aflibercept (Treatment Group B)Active Control2 Interventions
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
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
2,669 Total Patients Enrolled
Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc
5 Previous Clinical Trials
1,543 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial being conducted in multiple states?

"Right now, this particular clinical trial is being conducted by Retina Consultants of Southern California situated in Redlands, CA. Additionally, Springfield Clinic LLP in Springfield, IL and Retina Group of Washington located in Chevy Chase, MD are other active sites. There are a total 61 locations running this study."

Answered by AI

Could you please tell us the risks associated with taking KSI-301?

"KSI-301 was given a score of 3 by our team at Power. This is because it has progressed to phase 3 in clinical trials, which suggests that not only is there some evidence of its efficacy, but also that multiple rounds of testing have shown it to be safe."

Answered by AI

How many people are being enrolled in this clinical trial?

"As of right now, this clinical trial is not admitting any more patients. This study was first posted on June 15th, 2021 and was updated on June 2nd, 2022. There are currently 168 trials for macular degeneration and 51 studies for KSI-301 that are actively looking for participants."

Answered by AI

Could you please share what other research studies have been conducted that included KSI-301?

"KSI-301 was first researched in 2013 at the Massachusetts General Hospital. Up until now, there have been 251 completed studies. Currently, 51 clinical trials are still recruiting patients, with a large number of these taking place in Redlands, California."

Answered by AI

What medical condition is KSI-301 meant to target?

"KSI-301, which is most commonly used to treat wet age-related macular degeneration (WAMD), can also be used to ameliorate other visual conditions like macular edema, diabetic macular edema (DME), and general macular degeneration."

Answered by AI

Are patients needed for this research project?

"This particular trial is no longer enrolling patients. The listing was created on June 15th, 2021 and last updated on June 2nd, 2022. For those still seeking clinical trials, there are 168 active listings for macular degeneration and 51 for KSI-301."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
How old are they?
18 - 65
65+
What site did they apply to?
Retina Associates of Orange County
Northern California Retina Vitreous Associates
Retina Vitreous Associates of Florida
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am looking for a trial for my degenerative eye disorder.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A 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)
2021. "A 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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964089.
~145 spots leftby Apr 2025
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