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NCT04964089 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

A Phase 3 study of Wet Age-related Macular Degeneration, sponsored by Kodiak Sciences.

Completed
Registry status
Phase 3
Development phase
557
Enrollment target
20
Study locations

NCT04964089 is a Phase 3 study of Wet Age-related Macular Degeneration that has completed, run by Kodiak Sciences. The registered enrollment target is 557 participants, above the 355-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (57% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT04964089, a Phase 3 study of Wet Age-related Macular Degeneration, has completed, sponsored by Kodiak Sciences.

COMPLETED
Registry status
Phase 3
Development phase
557 participants
Enrollment target
20
Study locations

Study Summary

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Conditions Studied

Wet Age-related Macular Degeneration

Interventions

  • OTHER Sham Procedure
  • DRUG Aflibercept
  • DRUG KSI-301

Study Locations (20)

California

  • California Retina Consultants - Bakersfield
  • Eye Medical Center of Fresno - Fresno
  • Retina Consultants of Orange County - Fullerton
  • UCSD Jacobs Retina Center - La Jolla
  • Retina Associates of Orange County - Laguna Hills
  • Northern California Retina Vitreous Associates - Mountain View
  • Retina Consultants of San Diego - Poway
  • Retina Consultants of Southern California - Redlands
  • Retinal Consultants Medical Group Inc - Sacramento
  • Orange County Retina Medical Group - Santa Ana

Florida

  • Florida Eye Microsurgical Institute - Boynton Beach
  • Rand Eye Institute - Deerfield Beach
  • Retina Health Center - Fort Myers
  • National Ophthalmic Research Institute - Fort Myers
  • Florida Eye Associates - Melbourne
  • Retina Specialty Institute - Pensacola

Arizona

  • Retinal Research Institute, LLC - Phoenix

Arkansas

  • Northwest Arkansas Retina Associates - Springdale

Colorado

  • Colorado Retina Associates PC - Lakewood

Connecticut

  • Retina Group of New England - Waterford

Trial Details

FieldValue
Enrollment Target 557 participants
Start Date 2021-06-23
Est. Completion 2023-04-06
Phase Phase 3

Sponsor

Kodiak Sciences

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04964089

The ClinicalTrials.gov registry entry for NCT04964089 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 557 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 355-participant average among 8 other Wet Age-related Macular Degeneration trials with a reported enrollment target (57% higher). The listed sponsor is Kodiak Sciences, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Wet Age-related Macular Degeneration appearing as the primary indexed condition, and to 3 interventions - of which Sham Procedure is the first listed.

NCT04964089 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT04964089 about?

NCT04964089 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)". This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

What is the current status of trial NCT04964089?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2021-06-23. Estimated completion is 2023-04-06.

What conditions does trial NCT04964089 study?

This clinical trial studies the following conditions: Wet Age-related Macular Degeneration.

What interventions are being tested in trial NCT04964089?

The interventions under investigation include: Sham Procedure (OTHER), Aflibercept (DRUG), KSI-301 (DRUG).

Who is sponsoring clinical trial NCT04964089?

This trial is sponsored by Kodiak Sciences, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04964089 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.