A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

Wet Macular Degeneration Clinical Trial

— DAZZLE  

Official title:

A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04049266
• Other study ID #: KSI-CL-102
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 30, 2019
• Est. completion date: April 26, 2022

Study information

• Verified date: June 2022
• Source: Kodiak Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

Description:

This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg. At Week 52 patients on the aflibercept treatment arm will be re-randomized 1:1 into KSI-301 5 mg and aflibercept 2 mg.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 558
• Est. completion date: April 26, 2022
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to participation in the study.
• Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
• BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
• Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

• CNV secondary to other causes in the Study Eye.
• Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
• Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
• Active ocular or periocular infection or inflammation.
• Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
• Uncontrolled glaucoma in the Study Eye.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• Stroke or myocardial infarction in the 6-month period prior to Day 1.
• Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value =100 mmHg while at rest.
• 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.
• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet 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
Czechia	Axon Clinical, s.r.o.	Praha
Germany	Universitätsklinikum Bonn	Bonn
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Uniklinik Köln	Köln
Germany	Universitatsklinikum Leipzig	Leipzig
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga Eastern Clinical University Hospital Clinic Bikernieki	Riga
Poland	Oftalmika Sp. z o.o.	Bydgoszcz
Poland	Gabinet Okulistyczny prof. E. Wylegala	Katowice
Poland	Retina Okulistyka Sp. z o.o. Sp. km.	Warszawa
Slovakia	Fakultna nemocnica s poliklinikou Zilina	Žilina
Slovakia	Univerzitna nemocnica Bratislava	Bratislava
Slovakia	Nemocnica Trebisov - SVET ZDRAVIA - PPDS	Trebišov
Slovakia	Fakultna nemocnica Trencin	Trencín
Spain	Hospital dos de Maig	Barcelona
Spain	Institut de La Macula i La Retina	Barcelona
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Retina and Vitreous Center of Southern Oregon PC	Ashland	Oregon
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research, LLC	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Retina Vitreous Associates	Beverly Hills	California
United States	The Retina Center of New Jersey	Bloomfield	New Jersey
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida
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	Cascade Medical Research Institute	Eugene	Oregon
United States	Palmetto Retina Center	Florence	South Carolina
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 (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	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	Wills Eye Hospital	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	Sierra Eye Associates	Reno	Nevada
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	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Orange County Retina Medical Group	Santa Ana	California
United States	California Retina Consultants	Santa Maria	California
United States	Northwest Arkansas Retina Associates	Springdale	Arkansas
United States	New England Retina Consultants	Springfield	Massachusetts
United States	Springfield Clinic LLP	Springfield	Missouri
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	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Vitreo Retinal Consultants and Surgeons	Wichita	Kansas
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,  Czechia,  Germany,  Latvia,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.	BCVA is measured using ETDRS visual acuity charts.	Year 1
Secondary	Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.		Year 1
Secondary	Proportion of subjects who gain = 5, =10 and =15 letters from Day 1.		Year 1
Secondary	Proportion of subjects who lose = 5, =10 and =15 letters from Day 1.		Year 1
Secondary	Proportion of subjects with BCVA Snellen equivalent of 20/40 or better.		Year 1
Secondary	Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse.		Year 1
Secondary	Mean change in OCT central subfield retinal thickness (CST) from Day 1.		Year 1
Secondary	Mean change in OCT intraretinal fluid volume from Day 1.		Year 1
Secondary	Mean change in OCT subretinal fluid volume from Day 1.		Year 1
Secondary	Proportion of subjects without intraretinal fluid on OCT.		Year 1
Secondary	Proportion of subjects without subretinal fluid on OCT.		Year 1
Secondary	Mean change in CNV total lesion area on FA from baseline.		Year 1
Secondary	Mean chance in area of leakage on FA from baseline.		Year 1