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)

Wet Age-related Macular Degeneration Clinical Trial

— DAYLIGHT  

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 Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964089
• Other study ID #: KS301P107
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2021
• Est. completion date: April 6, 2023

Study information

• Verified date: May 2023
• Source: Kodiak Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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 neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: April 6, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to participation in the study.

• Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.

• BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.

• Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.

• Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

• BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).

• Active or suspected ocular or periocular infection or inflammation.

• CNV secondary to other causes in the Study Eye.

• Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.

• Uncontrolled glaucoma in the Study Eye.

• Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.

• Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.

• Women who are pregnant or lactating or intending to become pregnant during the study.

• 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.

• 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.

• Uncontrolled blood pressure defined as a systolic value =180 mmHg or diastolic value =100 mmHg while at rest.

• Other protocol-specified exclusion criteria may apply

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• KSI-301
Intravitreal Injection
• 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.

Locations

Country	Name	City	State
Puerto Rico	Emanuelli Research & Development Center LLC	Arecibo
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Research of Beaufort	Beaufort	South Carolina
United States	The Retina Center of New Jersey	Bloomfield	New Jersey
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation, Cole Eye Institute	Cleveland	Ohio
United States	Retina Associates of Cleveland	Cleveland	Ohio
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	Vitreoretinal Surgery PA	Edina	Minnesota
United States	Talley Eye	Evansville	Indiana
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Retina Health Center	Fort Myers	Florida
United States	Eye Medical Center of Fresno	Fresno	California
United States	Retina Consultants of Orange County	Fullerton	California
United States	Foundation for Vision Research	Grand Rapids	Michigan
United States	Cumberland Valley Retina Consultants PC	Hagerstown	Maryland
United States	Retina Consultants of Texas	Houston	Texas
United States	Retina Consultants of Texas-(Katy)	Katy	Texas
United States	Southeastern Retina Associates PC	Knoxville	Tennessee
United States	UCSD Jacobs Retina Center	La Jolla	California
United States	Charleston Neuroscience Institute	Ladson	South Carolina
United States	Retina Associates of Orange County	Laguna Hills	California
United States	Colorado Retina Associates PC	Lakewood	Colorado
United States	Retina Associates PA	Lenexa	Kansas
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Retina-Vitreous Surgeons of Central NY	Liverpool	New York
United States	Florida Eye Associates	Melbourne	Florida
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Retina Specialty Institute	Pensacola	Florida
United States	MidAtlantic Retina	Philadelphia	Pennsylvania
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Texas Retina Associates	Plano	Texas
United States	Retina Northwest	Portland	Oregon
United States	Retina Consultants of San Diego	Poway	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Retina Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Associates of Western NY	Rochester	New York
United States	Austin Retina Associates (Round Rock)	Round Rock	Texas
United States	Associated Retinal Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Medical Group Inc	Sacramento	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Retina Consultants, LLC	Salem	Oregon
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Orange County Retina Medical Group	Santa Ana	California
United States	Spokane Eye	Spokane	Washington
United States	Northwest Arkansas Retina Associates	Springdale	Arkansas
United States	Cascade Medical Research Institute	Springfield	Oregon
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Springfield Clinic LLP	Springfield	Illinois
United States	Retina Associates of Florida	Tampa	Florida
United States	NJ Retina	Teaneck	New Jersey
United States	Retina Consultants of Texas - (Woodlands)	The Woodlands	Texas
United States	Retina Group of New England	Waterford	Connecticut
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Vitreo Retinal Associates PC	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Kodiak Sciences Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.	Day 1 to Week 48
Secondary	Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.	Day 1 to Week 48
Secondary	Proportion of Patients Who Gain = 5, =10 and =15 Letters From Baseline Over Time	Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart	Day 1 to Week 48
Secondary	Proportion of Patients Who Lost = 5, =10 and =15 Letters From Baseline Over Time	Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart	Day 1 to Week 48
Secondary	Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (=69 ETDRS Letters)	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.	Day 1 to Week 48
Secondary	Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (=38 ETDRS Letters)	Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.	Day 1 to Week 48
Secondary	Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time	Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center.	Day 1 to Week 48