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.
- Conditions
- Wet Macular Degeneration
- Interventions
- Registration Number
- NCT04049266
- Lead Sponsor
- Kodiak Sciences Inc
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 559
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KSI-301 5 mg Sham Procedure Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: 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. Aflibercept 2 mg Aflibercept Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: 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. Aflibercept 2 mg Sham Procedure Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: 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. KSI-301 5 mg KSI-301 Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1 Year 1 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.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval Year 1 Percentage of subjects on KSI-301 arm achieving a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval based on individualized treatment response
Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1 Year 1 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
Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1 Year 1 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. BCVA Snellen equivalent of 20/40 was defined as ≥69 ETDRS letters
Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1 Year 1 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. BCVA Snellen equivalent of 20/200 or Worse was defined as BCVA ≤ 38 ETDRS Letters.
Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1 Year 1 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.
Trial Locations
- Locations (73)
Cleveland Clinic Foundation, Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Vitreoretinal Surgery PA
🇺🇸Edina, Minnesota, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Retina Vitreous Associates
🇺🇸Beverly Hills, California, United States
Northwest Arkansas Retina Associates
🇺🇸Springdale, Arkansas, United States
Eye Medical Center of Fresno
🇺🇸Fresno, California, United States
UCSD Jacobs Retina Center
🇺🇸La Jolla, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Consultants of San Diego
🇺🇸Poway, California, United States
Retinal Consultants Medical Group Inc
🇺🇸Sacramento, California, United States
Rand Eye Institute
🇺🇸Deerfield Beach, Florida, United States
Orange County Retina Medical Group
🇺🇸Santa Ana, California, United States
Colorado Retina Associates PC
🇺🇸Lakewood, Colorado, United States
Florida Eye Microsurgical Institute
🇺🇸Boynton Beach, Florida, United States
Retina Health Center
🇺🇸Fort Myers, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Retina Associates PA
🇺🇸Lenexa, Kansas, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Cumberland Valley Retina Consultants PC
🇺🇸Hagerstown, Maryland, United States
New England Retina Consultants
🇺🇸Springfield, Massachusetts, United States
Vitreo Retinal Associates PC
🇺🇸Worcester, Massachusetts, United States
Associated Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Springfield Clinic LLP
🇺🇸Springfield, Missouri, United States
The Retina Center of New Jersey
🇺🇸Bloomfield, New Jersey, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
NJ Retina
🇺🇸Teaneck, New Jersey, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Retina and Vitreous Center of Southern Oregon PC
🇺🇸Ashland, Oregon, United States
Retina Northwest
🇺🇸Portland, Oregon, United States
Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Cascade Medical Research Institute
🇺🇸Eugene, Oregon, United States
Palmetto Retina Center
🇺🇸Florence, South Carolina, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Retina Consultants of Texas
🇺🇸Bellaire, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Consultants of Texas (Katy)
🇺🇸Katy, Texas, United States
Texas Retina Associates
🇺🇸Plano, Texas, United States
Austin Retina Associates (Round Rock)
🇺🇸Round Rock, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Axon Clinical, s.r.o.
🇨🇿Praha, Czechia
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Uniklinik Köln
🇩🇪Köln, Germany
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Oftalmika Sp. z o.o.
🇵🇱Bydgoszcz, Poland
Riga Eastern Clinical University Hospital Clinic Bikernieki
🇱🇻Riga, Latvia
Gabinet Okulistyczny prof. E. Wylegala
🇵🇱Katowice, Poland
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Retina Okulistyka Sp. z o.o. Sp. km.
🇵🇱Warszawa, Poland
Institut de La Macula i La Retina
🇪🇸Barcelona, Spain
Hospital dos de Maig
🇪🇸Barcelona, Spain
Retina Associates of Florida
🇺🇸Tampa, Florida, United States
Austin Clinical Research, LLC
🇺🇸Austin, Texas, United States
California Retina Consultants
🇺🇸Santa Maria, California, United States
Retina Associates of Orange County
🇺🇸Laguna Hills, California, United States
Florida Eye Associates
🇺🇸Melbourne, Florida, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Vitreo Retinal Consultants and Surgeons
🇺🇸Wichita, Kansas, United States
Retina Consultants of Texas (Woodlands)
🇺🇸The Woodlands, Texas, United States
Foundation for Vision Research
🇺🇸Grand Rapids, Michigan, United States
Southeastern Retina Associates PC
🇺🇸Knoxville, Tennessee, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Nemocnica Trebisov - SVET ZDRAVIA - PPDS
🇸🇰Trebišov, Slovakia
Fakultna nemocnica s poliklinikou Zilina
🇸🇰Žilina, Slovakia
Fakultna nemocnica Trencin
🇸🇰Trenčín, Slovakia