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Trial record 2 of 4 for:    ksi-301

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 12, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE September 25, 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Macular Edema
  • Retinal Vein Occlusion
Intervention  ICMJE
  • Drug: KSI-301
    Intravitreal Injection
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: KSI-301
    • Other: Sham Procedure
  • 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.
    Interventions:
    • Drug: Aflibercept
    • Other: Sham Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2020)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kodiak Sciences Inc 1 (650) 281-0850 ksi301clinical@kodiak.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592419
Other Study ID Numbers  ICMJE KS301P103
2020-001061-37 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kodiak Sciences Inc
Study Sponsor  ICMJE Kodiak Sciences Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Janer, MD Kodiak Sciences Inc
PRS Account Kodiak Sciences Inc
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP