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Trial record 1 of 1 for:    Kodiak DAYLIGHT
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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) (DAYLIGHT)

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ClinicalTrials.gov Identifier: NCT04964089
Recruitment Status : Active, not recruiting
First Posted : July 15, 2021
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Drug: KSI-301 Drug: Aflibercept Other: Sham Procedure Phase 3

Detailed Description:

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 557 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KSI-301 (Treatment Group A)
Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
 Drug: KSI-301
Intravitreal Injection
Active Comparator: Aflibercept (Treatment Group B)
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.
 Drug: Aflibercept
Intravitreal Injection
Other Name: Eylea

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.


Outcome Measures
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Primary Outcome Measures :
  1. Non-inferiority of KSI-301 to aflibercept measured by changes in BCVA. [ Time Frame: Day 1 to Week 48 ]
    Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best-corrected visual acuity (BCVA).


Secondary Outcome Measures :
  1. Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA [ Time Frame: Day 1 to Week 48 ]
    Change from baseline in best corrected visual acuity (BCVA) between the two treatment arms.

  2. Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on OCT-CST [ Time Frame: Day 1 to Week 48 ]
    Change from baseline in central subfield thickness (CST) between the two treatment arms.

  3. Safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events [ Time Frame: Day 1 to Week 52 ]
    Incidence of ocular and systemic adverse events between the two treatment arms.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to participation in the study.
  • Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
  • Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
  • Active or suspected ocular or periocular infection or inflammation.
  • CNV secondary to other causes in the Study Eye.
  • Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
  • Uncontrolled glaucoma in the Study Eye.
  • Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
  • Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
  • History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
  • Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
  • Other protocol-specified exclusion criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964089


Locations
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Sponsors and Collaborators
Kodiak Sciences Inc
Investigators
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Study Director: Pablo Velazquez-Martin, MD Kodiak Sciences Inc
More Information
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Responsible Party: Kodiak Sciences Inc
ClinicalTrials.gov Identifier: NCT04964089    
Other Study ID Numbers: KS301P107
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kodiak Sciences Inc:
Kodiak
AMD
Wet AMD
neovascularization secondary to age-related macular degeneration
KSI-301
Aflibercept
Vascular endothelial growth factor
VEGF
Anti-VEGF
 Antibody biopolymer conjugate
Macular Degeneration
wAMD
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Vision, Low
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents