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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04603937
Other study ID # KS301P105
Secondary ID 2020-001063-82
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 30, 2020
Est. completion date August 31, 2023

Study information

Verified date September 2023
Source Kodiak Sciences Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.


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 treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.


Recruitment information / eligibility

Status Terminated
Enrollment 459
Est. completion date August 31, 2023
Est. primary completion date April 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent prior to participation in the study. 2. Treatment-naïve diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening. 3. BCVA ETDRS letter score between 78 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 DME. 6. Type 1 or Type 2 diabetes mellitus and a HbA1c of =12%. 7. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: 1. Macular edema in the Study Eye considered to be secondary to a cause other than DME. 2. Active iris or angle neovascularization or neovascular glaucoma in the Study Eye. 3. High-risk proliferative diabetic retinopathy characteristics in the Study Eye. 4. History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening. 5. Tractional retinal detachment in the Study Eye. 6. Active retinal disease other than the condition under investigation in the Study Eye. 7. Any history or evidence of a concurrent ocular condition present, 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 (e.g., vitreomacular traction, epiretinal membrane). 8. Active or suspected ocular or periocular infection or inflammation in either eye at Day 1. 9. Any prior use of an approved or investigational treatment for DME in the Study Eye (e.g., anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation). 10. Women who are pregnant or lactating or intending to become pregnant during the study. 11. Uncontrolled blood pressure defined as a systolic value = 180 mmHg or diastolic value =100 mmHg while at rest. 12. 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. 13. 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. 14. Other protocol-specified exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


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 OFTEX s.r.o. Pardubice
Czechia Lekarna BENU Praha
Czechia Vseobecna Fakultni Praha
France Centre Hospitalier Intercommunal de Créteil Créteil
France CHRU Dijon Complexe Du Bocage Dijon Côte-d'Or
France Hôpital de La Croix Rousse Lyon Rhône
France Centre Paradis Monticelli Marseille
France Fondation Rothschild Paris
France Hôpital Lariboisière - Service Pharmacie , Essais cliniques - Aude Jacob Paris
Hungary Bajcsy-Zsilinszky Korhaz es Rendelointezet Budapest
Hungary Budapest Retina Associates Kft Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház Nyíregyháza Szabolcs-Szatmár-Bereg
Israel Bnai Zion Haifa
Israel Rambam MC Haifa
Israel Hadassah University Hospital Jerusalem
Israel Meir MC Kfar Saba
Israel Rabin Medical Center Petach Tikva
Israel Kaplan MC Rehovot
Israel Assuta HaShalom Tel Aviv
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Shamir Medical Center Assaf Harofeh Tzrifin
Italy Ospedale San Raffaele S.r.l. - PPDS Milano Lombardia
Italy AOU dell'Università degli Studi della Campania Luigi Vanvitelli Naples
Italy Fondazione Policlinico Universitario A Gemelli Roma Lazio
Poland Oftalmika Sp. z o.o. Bydgoszcz
Poland Optimum Profesorskie Centrum Okulistyki Gdansk Pomorskie
Poland Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi Katowice Slaskie
Poland Specjalistyczny Szpital im. Alfreda Sokolowskiego Walbrzych
Poland Dr Nowosielska Okulistyka i Chirurgia Oka Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu Wroclaw
Puerto Rico Emanuelli Research & Development Center LLC Arecibo
United States Retina Consultants of Hawaii, Inc 'Aiea Hawaii
United States Retina Research Institute of Texas Abilene Texas
United States Asheville Eye Associates Asheville North Carolina
United States Southeast Retina Center Augusta Georgia
United States Austin Research Center for Retina Austin Texas
United States Retina Vitreous Associates Beverly Hills California
United States Retina Specialists of Idaho Boise Idaho
United States Florida Eye Microsurgical Institute Boynton Beach Florida
United States Cleveland Clinic Foundation, Cole Eye Institute Cleveland Ohio
United States Rand Eye Institute Deerfield Beach Florida
United States Talley Eye Evansville Indiana
United States National Ophthalmic Research Institute Fort Myers Florida
United States Texas Retina Associates Fort Worth Texas
United States Retina Consultants of Orange County Fullerton California
United States Vitreo Retinal Consultants Hauppauge New York
United States Retina Consultants of NV Henderson Nevada
United States Retina Consultants of Houston-(Katy) Katy Texas
United States Southeastern Retina Associates PC Knoxville Tennessee
United States Retina-Vitreous Surgeons of Central NY Liverpool New York
United States Georgia Retina, P.C. Marietta Georgia
United States Vitreoretinal Surgery PA Minneapolis Minnesota
United States Northern California Retina Vitreous Associates Mountain View California
United States Ophthalmic Consultants of Long Island Oceanside New York
United States Retinal Research Institute, LLC Phoenix Arizona
United States Texas Retina Associates Plano Texas
United States Fort Lauderdale Eye Institute Plantation Florida
United States Maine Eye Center Portland Maine
United States Retina Consultants of San Diego Poway California
United States Sierra Eye Associates Reno Nevada
United States Retina Institute of Virginia Richmond Virginia
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 Southern Vitreoretinal Associates Tallahassee Florida
United States Retina Consultants of Houston - (Woodlands) The Woodlands Texas
United States Retina Group of New England Waterford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Kodiak Sciences Inc

Countries where clinical trial is conducted

United States,  Czechia,  France,  Hungary,  Israel,  Italy,  Poland,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA. Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best corrected visual acuity (BCVA). Day 1 to Year 1
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in BCVA. Improvement in best corrected visual acuity (BCVA). Day 1 to Year 2
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in CST. Improvement in central subfield thickness (CST). Day 1 to Year 2
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in DRSS. Improvement if the diabetic retinopathy severity score (DRSS). Day 1 to Year 2
Secondary Durability of KSI-301 5 mg compared to aflibercept 2 mg measured by number of intravitreal injections during the study. Mean number of intravitreal injections during the course of the study. Day 1 to Year 2
Secondary Safety and Tolerability of KSI-301 mg compared to aflibercept 2 mg measured by the number of ocular and systemic adverse events. Incidence of ocular and systemic adverse events. Day 1 to Year 2
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