A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

Non-proliferative Diabetic Retinopathy Clinical Trial

— GLOW  

Official title:

A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05066230
• Other study ID #: KS301P106
• Status: Terminated
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: November 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 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Description:

This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 253
• Est. completion date: August 31, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent prior to participation in the study.
• Type 1 or 2 diabetes mellitus
• Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
• BCVA ETDRS letter score in the Study Eye of =69 letters (approximate Snellen equivalent of 20/40 or better)
• HbA1c of =12%.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Presence of center-involved DME in the Study Eye
• Prior PRP in the Study Eye.
• Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
• Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
• Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
• Prior use of an investigational intravitreal treatment for DR or DME 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 alter visual acuity during the study
• Active or suspected ocular or periocular infection or inflammation.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• 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.
• 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.
• 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

• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• KSI-301
Intravitreal injection

Other:
• Sham injection
The sham injection 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 is performed to maintain masking of the study.

Locations

Country	Name	City	State
Czechia	OFTEX s.r.o.	Pardubice	Pardubický Kraj
Czechia	Axon Clinical, s.r.o.	Praha 5
Latvia	Latvian American Eye Center	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Poland	Oftalmika Sp. z o.o.	Bydgoszcz
Poland	Optimum Profesorskie Centrum Okulistyki	Gdansk	Pomorskie
Poland	Warszawski Szpital Okulistyczny	Warszawa	Mazowieckie
Puerto Rico	Emanuelli Research & Development Center LLC	Arecibo
Slovakia	Fakultna nemocnica s poliklinikou F. D. Roosevelta	Banska Bystrica
Slovakia	Fakultna nemocnica Trencin	Trencin
Spain	Hospital Universitario de Bellvitge	L'hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Madrid	Majadanonda
Spain	Hospital Universitari General de Catalunya - Grupo Quironsalud	Sant Cugat del Valles	Barcelona
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Panhandle Eye Group, LLP	Amarillo	Texas
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	Charleston Neurosciences Institute	Beaufort	South Carolina
United States	Retina Consultants of Texas (Houston)	Bellaire	Texas
United States	MidAtlantic Retina	Bethlehem	Pennsylvania
United States	Retina Vitreous Associates	Beverly Hills	California
United States	Envision Ocular LLC	Bloomfield	New Jersey
United States	Retina Specialists of Idaho	Boise	Idaho
United States	Star Vision Consultants	Burleson	Texas
United States	Charleston Neuroscience Center	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	The Macula Center/ Blue Ocean Clinical Research	Clearwater	Florida
United States	Connecticut Eye Consultants	Danbury	Connecticut
United States	Cascade Medical Research Institute	Eugene	Oregon
United States	Retina Group of Florida	Fort Lauderdale	Florida
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	Long Island Vitreoretinal Consultants	Hauppauge	New York
United States	Graystone Eye	Hickory	North Carolina
United States	Retina Consultants of Texas (Katy)	Katy	Texas
United States	Southeastern Retina Associates PC	Knoxville	Tennessee
United States	Retina Associates PA	Lenexa	Kansas
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Florida Eye Associates	Melbourne	Florida
United States	Charles Retina Institute	Memphis	Tennessee
United States	Med Eye Associates	Miami	Florida
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Florida Retina Institute	Orlando	Florida
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Texas Retina Associates	Plano	Texas
United States	Retina Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Austin Retina Associates (Round Rock)	Round Rock	Texas
United States	Retinal Consultants Medical Group Inc	Sacramento	California
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Retina Consultants of San Antonio	San Antonio	Texas
United States	California Retina Consultants - Santa Maria	Santa Maria	California
United States	Spokane Eye	Spokane	Washington
United States	Springfield Clinic LLP	Springfield	Illinois
United States	Retina Consultants of Texas - (Woodlands)	The Woodlands	Texas
United States	Retina Group of New England	Waterford	Connecticut
United States	Center for Retina & Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Kodiak Sciences Inc

Countries where clinical trial is conducted

United States,  Czechia,  Latvia,  Poland,  Puerto Rico,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eyes improving =2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)		Day 1 to Week 48
Secondary	Proportion of eyes developing a Sight-Threatening Complication(s) of DR (DME, PDR, ASNV), as a composite and individually		Day 1 to Week 48 and Week 96
Secondary	Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually		Day 1 to Week 96
Secondary	Proportion of eyes improving =2 or =3 steps on the DRSS over time		Day 1 to Week 48 and Week 96
Secondary	Proportion of eyes worsening =2 or =3 steps on the DRSS over time		Day 1 to Week 48 and Week 96
Secondary	Safety and Tolerability of KSI-301 5 mg compared to sham treatment	Incidence of ocular and systemic adverse events	Day 1 to Week 100