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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)

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ClinicalTrials.gov Identifier: NCT04592419
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Brief Summary:
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Condition or disease Intervention/treatment Phase
Macular Edema Retinal Vein Occlusion 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 macular edema secondary to RVO (either branch and central type).

The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 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 Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: KS-301 (Arm A)
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.
Drug: KSI-301
Intravitreal Injection

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.

Active Comparator: Aflibercept (Arm B)
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 from Week 24 to Week 44.
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.




Primary Outcome Measures :
  1. Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA. [ Time Frame: Day 1 to Week 24 ]
    Demonstrate that KSI-301 5 mg administered every 8 weeks after 2 monthly doses is non-inferior to aflibercept 2 mg monthly 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 and CST. [ Time Frame: Day 1 to Week 44 ]
    Improvement in best corrected visual acuity (BCVA) and central subfield thickness (CST) between the two treatment arms.

  2. Durability of KSI-301 5 mg compared to aflibercept 2 mg based on number of intravitreal injections during the study. [ Time Frame: Week 1 to Week 44 ]
    Mean number of intravitreal injections during the course of the study between the two treatment arms.

  3. Safety and Tolerability of KSI-301 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 up to Week 24 and Week 52 between the two treatment arms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to participation in the study.
  2. 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.
  3. BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
  4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
  5. Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
  6. Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  1. Macular edema in the Study Eye for reasons other than RVO
  2. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
  3. Uncontrolled glaucoma in the Study Eye.
  4. Active retinal disease other than the condition under investigation in the Study Eye.
  5. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
  6. Active or suspected ocular or periocular infection or inflammation
  7. Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
  8. Women who are pregnant or lactating or intending to become pregnant during the study.
  9. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
  10. 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.
  11. 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.
  12. Other protocol-specified exclusion criteria may apply.

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): NCT04592419


Contacts
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Contact: Kodiak Sciences Inc 1 (650) 281-0850 ksi301clinical@kodiak.com

Locations
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Sponsors and Collaborators
Kodiak Sciences Inc
Investigators
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Study Director: Daniel Janer, MD Kodiak Sciences Inc
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Responsible Party: Kodiak Sciences Inc
ClinicalTrials.gov Identifier: NCT04592419    
Other Study ID Numbers: KS301P103
2020-001061-37 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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:
RVO
Kodiak
KSI-301
Vascular endothelial growth factor
Anti-VEGF
VEGF
Antibody biopolymer conjugate
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Vision, low
Aflibercept
Eylea
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases