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Wet Macular DegenerationPhase 2/3DAZZLENCT04049266

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.

A Phase 2/3 study testing KSI-301 and Aflibercept in people with Wet Macular Degeneration, run by Kodiak Sciences Inc at 75 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet 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
559 participants
Where
75 sitesin 7 countries
Study dates
8 Oct 2019to 26 Apr 2022
Phase
Phase 2/3
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.
  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

75 sites in 7 countries.

75 sites in 7 countries

United States59 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Retina and Vitreous Center of Southern Oregon PC

    Ashland, Oregon, 97520

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Clinical Research, LLC

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Associates of Cleveland

    Beachwood, Ohio, 44122

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Retina Vitreous Associates

    Beverly Hills, California, 90211

  • The Retina Center of New Jersey

    Bloomfield, New Jersey, 07017

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida, 33426

  • 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

  • Cascade Medical Research Institute

    Eugene, Oregon, 97401

  • Palmetto Retina Center

    Florence, South Carolina, 29501

  • 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 (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

  • 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

  • Wills Eye Hospital

    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

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • 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

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Maria, California, 93454

  • Northwest Arkansas Retina Associates

    Springdale, Arkansas, 72762

  • New England Retina Consultants

    Springfield, Massachusetts, 01103

  • Springfield Clinic LLP

    Springfield, Missouri, 62703

  • 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

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo Retinal Consultants and Surgeons

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Vitreo Retinal Associates PC

    Worcester, Massachusetts, 01603

Other trials in United States

Germany4 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Uniklinik Köln

    Cologne, 50937

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

Slovakia4 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 821 01

  • Nemocnica Trebisov - SVET ZDRAVIA - PPDS

    Trebišov, 075 01

  • Fakultna nemocnica Trencin

    Trenčín, 911 01

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 012 07

Other trials in Slovakia

Poland3 sites

  • Oftalmika Sp. z o.o.

    Bydgoszcz, 85-631

  • Gabinet Okulistyczny prof. E. Wylegala

    Katowice, 40-760

  • Retina Okulistyka Sp. z o.o. Sp. km.

    Warsaw, 01-364

Other trials in Poland

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Riga Eastern Clinical University Hospital Clinic Bikernieki

    Riga, 1038

Other trials in Latvia

Spain2 sites

  • Institut de La Macula i La Retina

    Barcelona, 08022

  • Hospital dos de Maig

    Barcelona, 08025

Other trials in Spain

Czechia1 site

  • Axon Clinical, s.r.o.

    Prague, 150 00

Other trials in Czechia

About this study

Official title: A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.

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).

Read the 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.

Being tested
KSI-301, Aflibercept, Sham Procedure
Keywords
AMD, Wet AMD, choroidal neovascularization secondary to age-related macular degeneration, KSI-301, Aflibercept, Vascular endothelial growth factor, VEGF, Anti-VEGF, Antibody biopolymer conjugate, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Kodiak
Medical subject headings
Wet Macular Degeneration, 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 NCT04049266
Study groupRoleWhat they receive
KSI-301 5 mgExperimentalDrug: 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.
Receives: Drug: KSI-301; Other: Sham Procedure
Aflibercept 2 mgActive comparatorDrug: 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.
Receives: Drug: Aflibercept; Other: Sham Procedure

What is being measured

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

  1. Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set 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.

    Measured: Year 1

Secondary outcomes (5)

  1. Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval

    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

    Measured: Year 1

  2. Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set 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

    Measured: Year 1

  3. Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at 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

    Measured: Year 1

  4. Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at 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.

    Measured: Year 1

  5. Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 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.

    Measured: Year 1

Timeline

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

  1. First posted8 Aug 2019
  2. Study start8 Oct 2019
  3. Primary completion17 Nov 2021
  4. Study completion26 Apr 2022

Why it stopped: Primary Endpoint Not Met

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04049266
Sponsor's protocol ID
KSI-CL-102
Acronym
DAZZLE
Status last verified
Jun 2024
First submitted
6 Aug 2019
Last updated
18 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 2/3 study testing KSI-301 and Aflibercept in people with Wet Macular Degeneration, run by Kodiak Sciences Inc at 75 sites in 7 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 18 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 75 sites in United States, Germany, Slovakia, Poland, Latvia and 2 more countries. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 Jul 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?

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1 (time frame: Year 1). 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 NCT04049266.

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 18 Jul 2024.

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