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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.

NCT04049266 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2024-07-18

Study results available
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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).

Conditions

  • Wet Macular Degeneration

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.

Sponsors & Collaborators

  • Kodiak Sciences Inc

    lead INDUSTRY

Principal Investigators

  • Pablo Velazquez-Martin, MD · Kodiak Sciences Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2021-11-17
Completion
2022-04-26
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Latvia
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049266 on ClinicalTrials.gov