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A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)

NCT05066230 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2024-09-05

Study results available
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Summary

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Conditions

Interventions

DRUG

KSI-301

Intravitreal injection

OTHER

Sham injection

The sham injection 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 is performed to maintain masking of the study.

Sponsors & Collaborators

  • Kodiak Sciences Inc

    lead INDUSTRY

Principal Investigators

  • Pablo Velazquez-Martin, MD · Kodiak Sciences Inc

  • Daniel Janer, 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
2021-09-07
Primary Completion
2023-08-03
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Latvia
  • Poland
  • Puerto Rico
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

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 NCT05066230 on ClinicalTrials.gov