A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

a study on Macular Edema Retinal Vein Occlusion

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Official Title

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Details

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch and central type). The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48. This includes an optional open-label, two-arm, double-masked Extension Phase in which participants completing the primary BEACON study are eligible to participate. All participants who enroll into the Extension Phase will be treated with KSI-301 5 mg. The Extension Phase will have the final study assessment at Week 72 for efficacy endpoints and a final safety follow-up at Week 76.

Keywords

Macular Edema Retinal Vein Occlusion RVO Kodiak KSI-301 Vascular endothelial growth factor Anti-VEGF VEGF Antibody biopolymer conjugate Retinal Degeneration Retinal Diseases Eye Diseases Vision Disorders Vision, low Aflibercept Eylea Edema

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Signed informed consent prior to participation in the study.
  2. Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
  3. BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
  4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
  5. Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
  6. Other protocol-specified inclusion criteria may apply.

You CAN'T join if...

  1. Macular edema in the Study Eye for reasons other than RVO
  2. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
  3. Uncontrolled glaucoma in the Study Eye.
  4. Active retinal disease other than the condition under investigation in the Study Eye.
  5. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
  6. Active or suspected ocular or periocular infection or inflammation
  7. Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
  8. Women who are pregnant or lactating or intending to become pregnant during the study.
  9. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
  10. . Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
  11. . 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.
  12. . Other protocol-specified exclusion criteria may apply.

Locations

  • UCSD Jacobs Retina Center accepting new patients
    La Jolla California 92037 United States
  • Retina Consultants of San Diego accepting new patients
    Poway California 92064 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kodiak Sciences Inc
ID
NCT04592419
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 550 study participants
Last Updated
Contact us about this trial