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.

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2021

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.

Interventions

  • Drug: KSI-301
    • Intravitreal Injection
  • Drug: Aflibercept
    • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kodiak Sciences Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Kodiak Sciences Inc, +1 (650) 281-0850, KSI-CL-102@kodiak.com

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