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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

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).

Condition or disease Intervention/treatment Phase
Wet Macular Degeneration Drug: KSI-301 Drug: Aflibercept Other: Sham Procedure Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
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
Official Title: 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.
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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 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.

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. Mean change in Best Corrected Visual Acuity (BCVA) from Day 1. [ Time Frame: Year 1 ]
    BCVA is measured using ETDRS visual acuity charts.


Secondary Outcome Measures :
  1. Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301. [ Time Frame: Year 1 ]
  2. Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1. [ Time Frame: Year 1 ]
  3. Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1. [ Time Frame: Year 1 ]
  4. Proportion of subjects with BCVA Snellen equivalent of 20/40 or better. [ Time Frame: Year 1 ]
  5. Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse. [ Time Frame: Year 1 ]
  6. Mean change in OCT central subfield retinal thickness (CST) from Day 1. [ Time Frame: Year 1 ]
  7. Mean change in OCT intraretinal fluid volume from Day 1. [ Time Frame: Year 1 ]
  8. Mean change in OCT subretinal fluid volume from Day 1. [ Time Frame: Year 1 ]
  9. Proportion of subjects without intraretinal fluid on OCT. [ Time Frame: Year 1 ]
  10. Proportion of subjects without subretinal fluid on OCT. [ Time Frame: Year 1 ]
  11. Mean change in CNV total lesion area on FA from baseline. [ Time Frame: Year 1 ]
  12. Mean chance in area of leakage on FA from baseline. [ Time Frame: Year 1 ]


Information from the National Library of Medicine

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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.
  • 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.

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): NCT04049266


Contacts
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Contact: Kodiak Sciences Inc +1 (650) 281-0850 KSI-CL-102@kodiak.com

Locations
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United States, Texas
Austin Retina Associates Recruiting
Austin, Texas, United States, 78705
Sponsors and Collaborators
Kodiak Sciences Inc

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Responsible Party: Kodiak Sciences Inc
ClinicalTrials.gov Identifier: NCT04049266     History of Changes
Other Study ID Numbers: KSI-CL-102
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
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:
AMD
Wet AMD
choroidal neovascularization secondary to age-related macular degeneration
KSI-301
Aflibercept
Vascular endothelial growth factor
VEGF
Anti-VEGF
Antibody biopolymer conjugate
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Vision, low
Kodiak
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs