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Wet Age-related Macular DegenerationPhase 3DAYLIGHTNCT04964089

A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

A Phase 3 study testing KSI-301 and Aflibercept in people with Wet Age-related Macular Degeneration, run by Kodiak Sciences Inc at 66 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD) Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
KSI-301 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
557 participants
Where
66 sitesin 2 countries
Study dates
23 Jun 2021to 6 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to participation in the study.
  • Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
  • Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
  • Other protocol-specified inclusion criteria may apply

Who cannot join

  • BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
  • Active or suspected ocular or periocular infection or inflammation.
  • CNV secondary to other causes 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 affect macular edema or alter visual acuity during the study.
  • Uncontrolled glaucoma in the Study Eye.
  • Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
Show all 12Show fewer
  • Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • 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.
  • 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.
  • 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

Trial locations and contacts

66 sites in 2 countries.

66 sites in 2 countries

United States65 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Research of Beaufort

    Beaufort, South Carolina, 29902

  • The Retina Center of New Jersey

    Bloomfield, New Jersey, 07017

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida, 33426

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • University of Chicago

    Chicago, Illinois, 60637

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130

  • Cleveland Clinic Foundation, Cole Eye Institute

    Cleveland, Ohio, 44195

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Vitreoretinal Surgery PA

    Edina, Minnesota, 55435

  • Talley Eye

    Evansville, Indiana, 47710

  • Retina Health Center

    Fort Myers, Florida, 33907

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Eye Medical Center of Fresno

    Fresno, California, 93720

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49525

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Retina Consultants of Texas-(Katy)

    Katy, Texas, 77494

  • Southeastern Retina Associates PC

    Knoxville, Tennessee, 37909

  • UCSD Jacobs Retina Center

    La Jolla, California, 92037

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Retina Associates of Orange County

    Laguna Hills, California, 92653

  • Colorado Retina Associates PC

    Lakewood, Colorado, 80228

  • Retina Associates PA

    Lenexa, Kansas, 66215

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Retina-Vitreous Surgeons of Central NY

    Liverpool, New York, 13088

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • MidAtlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Texas Retina Associates

    Plano, Texas, 75075

  • Retina Northwest

    Portland, Oregon, 97210

  • Retina Consultants of San Diego

    Poway, California, 92064

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western NY

    Rochester, New York, 14620

  • Austin Retina Associates (Round Rock)

    Round Rock, Texas, 78681

  • Associated Retinal Consultants PC

    Royal Oak, Michigan, 78073

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95819

  • Retina Consultants, LLC

    Salem, Oregon, 97302

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • Spokane Eye

    Spokane, Washington, 99204

  • Northwest Arkansas Retina Associates

    Springdale, Arkansas, 72762

  • Springfield Clinic LLP

    Springfield, Illinois, 62703

  • New England Retina Consultants

    Springfield, Massachusetts, 01103

  • Cascade Medical Research Institute

    Springfield, Oregon, 97477

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33703

  • Retina Associates of Florida

    Tampa, Florida, 33609

  • NJ Retina

    Teaneck, New Jersey, 07605

  • Retina Consultants of Texas - (Woodlands)

    The Woodlands, Texas, 77384

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Palmetto Retina Center

    West Columbia, South Carolina, 296169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Vitreo Retinal Associates PC

    Worcester, Massachusetts, 01603

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research & Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Read the 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 visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Being tested
KSI-301, Aflibercept, Sham Procedure
Keywords
AMD, Wet AMD, neovascularization secondary to age-related macular degeneration, KSI-301, Aflibercept, Vascular endothelial growth factor, VEGF, Anti-VEGF, Antibody biopolymer conjugate, Macular Degeneration, wAMD, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, Low, Kodiak
Medical subject headings
Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KSI-301Drug

    Intravitreal Injection

  • AfliberceptDrug

    Also called Eylea

    Intravitreal Injection

  • Sham ProcedureOther

    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.

Study groups in NCT04964089
Study groupRoleWhat they receive
KSI-301 (Treatment Group A)ExperimentalIntravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
Receives: Drug: KSI-301
Aflibercept (Treatment Group B)Active comparatorIntravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Receives: Drug: Aflibercept; Other: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.

    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.

    Measured: Day 1 to Week 48

Secondary outcomes (6)

  1. Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time

    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.

    Measured: Day 1 to Week 48

  2. Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time

    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

    Measured: Day 1 to Week 48

  3. Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time

    Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart

    Measured: Day 1 to Week 48

  4. Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters)

    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.

    Measured: Day 1 to Week 48

  5. Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters)

    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.

    Measured: Day 1 to Week 48

  6. Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time

    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.

    Measured: Day 1 to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start23 Jun 2021
  3. Primary completion28 Mar 2023
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04964089
Sponsor's protocol ID
KS301P107
Acronym
DAYLIGHT
Status last verified
Jun 2024
First submitted
6 Jul 2021
Last updated
3 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KSI-301 and Aflibercept in people with Wet Age-related Macular Degeneration, run by Kodiak Sciences Inc at 66 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. (time frame: Day 1 to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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