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A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (DAZZLE)

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ClinicalTrials.gov Identifier: NCT04049266
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE September 30, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Mean change in Best Corrected Visual Acuity (BCVA) from Day 1. [ Time Frame: Year 1 ]
BCVA is measured using ETDRS visual acuity charts.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04049266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301. [ Time Frame: Year 1 ]
  • Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1. [ Time Frame: Year 1 ]
  • Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1. [ Time Frame: Year 1 ]
  • Proportion of subjects with BCVA Snellen equivalent of 20/40 or better. [ Time Frame: Year 1 ]
  • Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse. [ Time Frame: Year 1 ]
  • Mean change in OCT central subfield retinal thickness (CST) from Day 1. [ Time Frame: Year 1 ]
  • Mean change in OCT intraretinal fluid volume from Day 1. [ Time Frame: Year 1 ]
  • Mean change in OCT subretinal fluid volume from Day 1. [ Time Frame: Year 1 ]
  • Proportion of subjects without intraretinal fluid on OCT. [ Time Frame: Year 1 ]
  • Proportion of subjects without subretinal fluid on OCT. [ Time Frame: Year 1 ]
  • Mean change in CNV total lesion area on FA from baseline. [ Time Frame: Year 1 ]
  • Mean chance in area of leakage on FA from baseline. [ Time Frame: Year 1 ]
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 and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Official Title  ICMJE A Phase 2, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
Brief Summary This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Detailed Description This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg. At Week 52 patients on the aflibercept treatment arm will be re-randomized 1:1 into KSI-301 5 mg and aflibercept 2 mg.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
A masked evaluating investigator will be responsible for subject care except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections.
Primary Purpose: Treatment
Condition  ICMJE Wet Macular Degeneration
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: KSI-301 5 mg

    Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol.

    Drug: 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.

    Interventions:
    • Drug: KSI-301
    • Other: Sham Procedure
  • Active Comparator: Aflibercept 2 mg

    Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.

    Drug: 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.

    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: August 6, 2019)
368
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent prior to participation in the study.
  • Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • CNV secondary to other causes in the Study Eye.
  • Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
  • Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
  • Active ocular or periocular infection or inflammation.
  • Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
  • Uncontrolled glaucoma in the Study Eye.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • Stroke or myocardial infarction in the 6-month period prior to Day 1.
  • Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest.
  • 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.
  • Other protocol-specified exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kodiak Sciences Inc +1 (650) 281-0850 KSI-CL-102@kodiak.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04049266
Other Study ID Numbers  ICMJE KSI-CL-102
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 Not Provided
PRS Account Kodiak Sciences Inc
Verification Date October 2019

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