A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

NCT ID: NCT04603937

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-08-31

Brief Summary

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

Detailed 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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

KSI-301 (Arm A)

Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100.

Group Type: EXPERIMENTAL

KSI-301

Intervention Type: DRUG

Intravitreal Injection

Sham Procedure

Intervention Type: OTHER

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 (Arm B)

Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100.

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Intravitreal Injection

Sham Procedure

Intervention Type: OTHER

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.

Interventions

KSI-301

Intravitreal Injection

Intervention Type: DRUG

Aflibercept

Intravitreal Injection

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Eylea

Eligibility Criteria

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%.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kodiak Sciences Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Velazquez-Martin, MD

Role: STUDY_DIRECTOR

Kodiak Sciences Inc

Locations

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Retina Vitreous Associates

Beverly Hills, California, United States

Retina Consultants of Orange County

Fullerton, 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

Retina Group of New England

Waterford, Connecticut, United States

Florida Eye Microsurgical Institute

Boynton Beach, Florida, United States

Rand Eye Institute

Deerfield Beach, Florida, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Southern Vitreoretinal Associates

Tallahassee, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

Georgia Retina, P.C.

Marietta, Georgia, United States

Retina Consultants of Hawaii, Inc

‘Aiea, Hawaii, United States

Retina Specialists of Idaho

Boise, Idaho, United States

Talley Eye

Evansville, Indiana, United States

Maine Eye Center

Portland, Maine, United States

Associated Retinal Consultants PC

Royal Oak, Michigan, United States

Vitreoretinal Surgery PA

Minneapolis, Minnesota, United States

Retina Consultants of NV

Henderson, Nevada, United States

Sierra Eye Associates

Reno, Nevada, United States

Vitreo Retinal Consultants

Hauppauge, New York, United States

Retina-Vitreous Surgeons of Central NY

Liverpool, New York, United States

Ophthalmic Consultants of Long Island

Oceanside, New York, United States

Retina Associates of Western NY

Rochester, New York, United States

Asheville Eye Associates

Asheville, North Carolina, United States

Cleveland Clinic Foundation, Cole Eye Institute

Cleveland, Ohio, United States

Retina Consultants, LLC

Salem, Oregon, United States

Southeastern Retina Associates PC

Knoxville, Tennessee, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Austin Research Center for Retina

Austin, Texas, United States

Texas Retina Associates

Fort Worth, Texas, United States

Retina Consultants of Houston-(Katy)

Katy, Texas, United States

Texas Retina Associates

Plano, Texas, United States

Austin Retina Associates (Round Rock)

Round Rock, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Retina Consultants of Houston - (Woodlands)

The Woodlands, Texas, United States

Retina Institute of Virginia

Richmond, Virginia, United States

OFTEX s.r.o.

Pardubice, , Czechia

Vseobecna Fakultni

Prague, , Czechia

Lekarna BENU

Prague, , Czechia

CHRU Dijon Complexe Du Bocage

Dijon, Côte-d'Or, France

Hôpital de La Croix Rousse

Lyon, Rhône, France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Centre Paradis Monticelli

Marseille, , France

Hôpital Lariboisière - Service Pharmacie , Essais cliniques - Aude Jacob

Paris, , France

Fondation Rothschild

Paris, , France

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Semmelweis Egyetem

Budapest, , Hungary

Bajcsy-Zsilinszky Korhaz es Rendelointezet

Budapest, , Hungary

Budapest Retina Associates Kft

Budapest, , Hungary

Bnai Zion

Haifa, , Israel

Rambam MC

Haifa, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Meir MC

Kfar Saba, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Kaplan MC

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Assuta HaShalom

Tel Aviv, , Israel

Shamir Medical Center Assaf Harofeh

Tzrifin, , Israel

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

Ospedale San Raffaele S.r.l. - PPDS

Milan, Lombardy, Italy

AOU dell'Università degli Studi della Campania Luigi Vanvitelli

Naples, , Italy

Optimum Profesorskie Centrum Okulistyki

Gdansk, Pomeranian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

Katowice, Silesian Voivodeship, Poland

Oftalmika Sp. z o.o.

Bydgoszcz, , Poland

Dr Nowosielska Okulistyka i Chirurgia Oka

Warsaw, , Poland

Specjalistyczny Szpital im. Alfreda Sokolowskiego

Wałbrzych, , Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, , Poland

Emanuelli Research & Development Center LLC

Arecibo, , Puerto Rico

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-001063-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KS301P105

Identifier Type: -

Identifier Source: org_study_id