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A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

NCT04603937 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2024-08-22

Study results available
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Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

Conditions

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-04-27
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Poland
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04603937 on ClinicalTrials.gov