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Non-proliferative Diabetic RetinopathyPhase 3GLOWNCT05066230

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

A Phase 3 study testing KSI-301 in people with Non-proliferative Diabetic Retinopathy, run by Kodiak Sciences Inc at 61 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 Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-proliferative Diabetic Retinopathy
What is being tested?
KSI-301
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
253 participants
Where
61 sitesin 7 countries
Study dates
7 Sep 2021to 31 Aug 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 18 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.
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

61 sites in 7 countries.

61 sites in 7 countries

United States46 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Panhandle Eye Group, LLP

    Amarillo, Texas, 79106

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Charleston Neurosciences Institute

    Beaufort, South Carolina, 29902

  • Retina Consultants of Texas (Houston)

    Bellaire, Texas, 77401

  • MidAtlantic Retina

    Bethlehem, Pennsylvania, 18017-9412

  • Retina Vitreous Associates

    Beverly Hills, California, 90211

  • Envision Ocular LLC

    Bloomfield, New Jersey, 07003

  • Retina Specialists of Idaho

    Boise, Idaho, 83713

  • Star Vision Consultants

    Burleson, Texas, 76028

  • Charleston Neuroscience Center

    Charleston, South Carolina, 29414

  • University of Chicago

    Chicago, Illinois, 60637

  • The Macula Center/ Blue Ocean Clinical Research

    Clearwater, Florida, 33761

  • Connecticut Eye Consultants

    Danbury, Connecticut, 06810

  • Cascade Medical Research Institute

    Eugene, Oregon, 97401

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49525

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Long Island Vitreoretinal Consultants

    Hauppauge, New York, 11788

  • Graystone Eye

    Hickory, North Carolina, 28603-2588

  • Retina Consultants of Texas (Katy)

    Katy, Texas, 77494

  • Southeastern Retina Associates PC

    Knoxville, Tennessee, 37909

  • Retina Associates PA

    Lenexa, Kansas, 66215

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Charles Retina Institute

    Memphis, Tennessee, 38119-4823

  • Med Eye Associates

    Miami, Florida, 33143

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Texas Retina Associates

    Plano, Texas, 75075

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Austin Retina Associates (Round Rock)

    Round Rock, Texas, 78681

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95825

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Consultants of San Antonio

    San Antonio, Texas, 78240

  • California Retina Consultants - Santa Maria

    Santa Maria, California, 93454

  • Spokane Eye

    Spokane, Washington, 99204

  • Springfield Clinic LLP

    Springfield, Illinois, 62703

  • Retina Consultants of Texas - (Woodlands)

    The Woodlands, Texas, 77384

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Center for Retina & Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Spain5 sites

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, Majadanonda, 28220

  • Hospital Universitari General de Catalunya - Grupo Quironsalud

    Sant Cugat del Vallès, Barcelona, 08195

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50001

  • Hospital Universitario Miguel Servet

    Zaragoza, 50006

Other trials in Spain

Poland3 sites

  • Oftalmika Sp. z o.o.

    Bydgoszcz, 85-631

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, Pomeranian Voivodeship, 80-952

  • Warszawski Szpital Okulistyczny

    Warsaw, Masovian Voivodeship, 01-258

Other trials in Poland

Czechia2 sites

  • OFTEX s.r.o.

    Pardubice, Pardubice Region, 530 02

  • Axon Clinical, s.r.o.

    Prague, 15 0 00

Other trials in Czechia

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Latvian American Eye Center

    Riga, LV-1009

Other trials in Latvia

Slovakia2 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banská Bystrica, 975 17

  • Fakultna nemocnica Trencin

    Trenčín, 911 71

Other trials in Slovakia

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, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

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).

Read the detailed 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.

Being tested
KSI-301, Sham injection
Keywords
Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy, NPDR, KSI-301, VEGF, Anti-VEGF, Vascular Endothelial Growth Factor, Antibody Biopolymer Conjugate, Retinal Degeneration, Retinal Diseases, Eye Diseases, Retinopathy, Vision Disorders, Kodiak
Medical subject headings
Diabetic Retinopathy, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders

What participants receive

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

  • KSI-301Drug

    Intravitreal injection

  • Sham injectionOther

    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.

Study groups in NCT05066230
Study groupRoleWhat they receive
KSI-301 - Treatment Group AExperimentalIntravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
Receives: Drug: KSI-301
Treatment Group BSham comparatorSham injection on the same schedule as Treatment Group A
Receives: Other: Sham injection

What is being measured

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

  1. Percentage of Patients Improving ≥2 Steps on DRSS

    Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

    Measured: Day 1 to Week 48

Secondary outcomes (11)

  1. Percentage of Patients Developing Any Sight-Threatening Complication

    Percentage of patients developing any of the following Sight-Threatening Complication: Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), Vitreous hemorrhage or tractional retinal detachment believed to be due to PDR, or Diabetic Macular Edema (DME) from baseline through Week 48

    Measured: Day 1 to Week 48

  2. Percentage of Patients Improving ≥3 Steps on DRSS

    Percentage of patients improving ≥3 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

    Measured: Day 1 to Week 48

  3. Percentage of Patients Developing PDR

    Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48

    Measured: Day 1 to Week 48

  4. Percentage of Patients Developing PDR or ASNV

    Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) from baseline through Week 48

    Measured: Day 1 to Week 48

  5. Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR

    Percentage of patients developing vitreous hemorrhage or tractional retinal detachment believed to be due to Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48

    Measured: Day 1 to Week 48

  6. Percentage of Patients Developing DME

    Percentage of patients developing Diabetic Macular Edema (DME) from baseline through Week 48

    Measured: Day 1 to Week 48

  7. Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS

    Percentage of patients with a ≥2-step or ≥3-step worsening on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

    Measured: Day 1 to Week 48

  8. Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA

    Percentage of patients who lost ≥5, ≥10, or ≥15 letters in Best-corrected Visual Acuity (BCVA) from baseline 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

  9. Time to First Development of PDR, ASNV, or DME

    Time to first development of Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), or Diabetic Macular Edema (DME) through Week 48

    Measured: Day 1 to Week 48

  10. Time to First Development of PDR or ASNV

    Time to first development of Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) through Week 48

    Measured: Day 1 to Week 48

  11. Time to First Development of Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR

    Time to first development of vitreous hemorrhage or tractional retinal detachment believed to be due to Proliferative Diabetic Retinopathy (PDR) through Week 48

    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 posted4 Oct 2021
  2. Study start7 Sep 2021
  3. Primary completion3 Aug 2023
  4. Study completion31 Aug 2023

Why it stopped: All patients completed the primary endpoint assessments. Additional follow-up after the primary endpoint was deemed not necessary by the Sponsor.

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 arms: KSI-301 or sham.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066230
Sponsor's protocol ID
KS301P106
Acronym
GLOW
Status last verified
Aug 2024
First submitted
23 Sep 2021
Last updated
5 Sep 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 in people with Non-proliferative Diabetic Retinopathy, run by Kodiak Sciences Inc at 61 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 6 inclusion and 13 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Spain, Poland, Czechia, 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. Some participants in this study may receive a placebo. 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 5 Sep 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?

Percentage of Patients Improving ≥2 Steps on DRSS (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 NCT05066230.

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 5 Sep 2024.

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