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TerminatedNCT04603937GLIMMERUpdated Aug 22, 2024Results posted

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

A Phase 3 interventional study of KSI-301 and Aflibercept in Diabetic Macular Edema, sponsored by Kodiak Sciences Inc. Terminated at 72 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Kodiak Sciences Inc · Phase 3, Interventional, and Treatment

Why this study was terminated
Study did not meet primary endpoint
Phase
Phase 3
Study type
Interventional
Enrollment
459
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

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 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.

02

Conditions studied

  • Diabetic Macular Edema

Keywords

  • DME
  • Kodiak
  • Vascular endothelial growth factor
  • Anti-VEGF
  • VEGF
  • Antibody biopolymer conjugate
  • Retinal Degeneration
  • Retinal Diseases
  • Eye Diseases
  • Vision Disorders
  • Vision, low
  • Aflibercept
  • Eylea
  • Diabetes mellitus
  • Diabetes
  • Diabetic retinopathy
  • Diabetic macular edema
  • Macular edema
  • KSI-301
03

In context

Macular Edema

842 studies on the registry are indexed under Macular Edema; 57 are open to participants now.

This study's enrollment of 459 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Kodiak Sciences Inc is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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%.
  7. Other protocol-specified inclusion criteria may apply.

Exclusion criteria

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.
  14. Other protocol-specified exclusion criteria may apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
459 participants (actual)

Study arms

  • Experimental
    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.

    Drug: KSI-301 · Other: Sham Procedure

  • Active comparator
    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.

    Drug: Aflibercept · Other: Sham Procedure

Interventions

  • DrugKSI-301

    Intravitreal Injection

  • DrugAflibercept

    Intravitreal Injection

    Also known as: Eylea

  • OtherSham 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.

06

What researchers measure

Primary outcomes

  1. Mean Change in BCVA

    Mean change in best-corrected visual acuity (BCVA) from baseline to the average of Weeks 60 and 64 (using Early Treatment Diabetic Retinopathy Study (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.

    Time frame: Day 1 to Week 64

Secondary outcomes

  1. Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined

    Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Studies KS301P104 and KS301P105 combined. 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).

    Time frame: Day 1 to Week 52

  2. Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P105

    Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Study KS301P105. 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).

    Time frame: Day 1 to Week 52

  3. Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval

    Percentage of patients in the KSI-301 arm on a Q8W, Q12W, Q16W, Q20W, or Q24W treatment interval at the primary endpoint. Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards.

    Time frame: Week 56

  4. Mean Number of Intravitreal Injections

    Mean number of intravitreal injections from Day 1 to Week 60

    Time frame: Day 1 to Week 60

  5. Mean Change in OCT CST

    Mean change in Optical Coherence Tomography (OCT) central subfield retinal thickness (CST) baseline to the average of Weeks 60 and 64

    Time frame: Day 1 to Week 64

07

Results

Posted Aug 22, 2024

Participant flow

Participants were recruited based on physician referral at 75 medical centers between September 2020 and January 2022. The first participant was enrolled on 30 September 2020 and the last on 31 January 2022.

Participant flow — Overall Study
MilestoneKSI-301 (Arm A)Aflibercept (Arm B)
Started229228
Completed208204
Not completed2124
Withdrew: Adverse event910
Withdrew: Withdrawal by subject76
Withdrew: Lost to follow-up56
Withdrew: Physician decision01
Withdrew: Subject did not meet inclusion criteria 1 so was withdrawn from the study01

Outcome measures

PrimaryMean Change in BCVA

Mean change in best-corrected visual acuity (BCVA) from baseline to the average of Weeks 60 and 64 (using Early Treatment Diabetic Retinopathy Study (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.

Time frame:
Day 1 to Week 64
Reported as:
Least squares mean · ETDRS Letters
Mean Change in BCVA
ETDRS LettersKSI-301 (Arm A)Aflibercept (Arm B)
Mean Change in BCVA6.7 ± 0.8011.5 ± 0.81
Statistical analysis
  • KSI-301 (Arm A) vs Aflibercept (Arm B) · Mixed Models Analysis · p = > 0.9999 · Adjusted mean difference: -4.7 · 95.04% CI -6.65 to -2.81MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.
SecondaryPercentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined

Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Studies KS301P104 and KS301P105 combined. 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).

Time frame:
Day 1 to Week 52
Reported as:
Count of participants · Participants
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined
ParticipantsKSI-301 (Arm A)Aflibercept (Arm B)
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined63
Statistical analysis
  • KSI-301 (Arm A) vs Aflibercept (Arm B) · Cochran-Mantel-Haenszel · p = <0.0001 · Difference of weighted percentages: 0.6 · 95.04% CI -0.7 to 2Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.
SecondaryPercentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P105

Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Study KS301P105. 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).

Time frame:
Day 1 to Week 52
Reported as:
Count of participants · Participants
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P105
ParticipantsKSI-301 (Arm A)Aflibercept (Arm B)
Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P10563
Statistical analysis
  • KSI-301 (Arm A) vs Aflibercept (Arm B) · Cochran-Mantel-Haenszel · p = <0.0001 · Difference of weighted percentages: 1.2 · 95.04% CI -1.4 to 3.9Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.
SecondaryPercentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval

Percentage of patients in the KSI-301 arm on a Q8W, Q12W, Q16W, Q20W, or Q24W treatment interval at the primary endpoint. Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards.

Time frame:
Week 56
Reported as:
Count of participants · Participants
Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval
ParticipantsKSI-301 (Arm A)
Number of participants on the KSI-301 Q8W54
Number of participants on the KSI-301 Q12W23
Number of participants on the KSI-301 Q16W14
Number of participants on the KSI-301 Q20W10
Number of participants on the KSI-301 Q24W109
SecondaryMean Number of Intravitreal Injections

Mean number of intravitreal injections from Day 1 to Week 60

Time frame:
Day 1 to Week 60
Reported as:
Mean · injections
Mean Number of Intravitreal Injections
injectionsKSI-301 (Arm A)Aflibercept (Arm B)
Mean Number of Intravitreal Injections5.8 ± 1.649.2 ± 1.91
SecondaryMean Change in OCT CST

Mean change in Optical Coherence Tomography (OCT) central subfield retinal thickness (CST) baseline to the average of Weeks 60 and 64

Time frame:
Day 1 to Week 64
Reported as:
Mean · Microns
Mean Change in OCT CST
MicronsKSI-301 (Arm A)Aflibercept (Arm B)
Mean Change in OCT CST-154.7 ± 128.03-194.2 ± 154.44

Adverse events

Collected over Time Frame Adverse Events (AEs) reported through Week 64 or Early Termination (ET) if occurred before Week 64.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KSI-301 (Arm A)4/228 (1.8%)53/228 (23.2%)113/228 (49.6%)
Aflibercept (Arm B)6/229 (2.6%)57/229 (24.9%)104/229 (45.4%)
Most frequent serious events
Showing 10 of 128
Most frequent serious events
EventKSI-301 (Arm A)Aflibercept (Arm B)
PneumoniaInfections and infestations5/2282/229
Acute kidney injuryRenal and urinary disorders4/2282/229
Acute myocardial infarctionCardiac disorders3/2284/229
Cardiac failure congestiveCardiac disorders1/2284/229
COVID-19Infections and infestations3/2284/229
COVID-19 pneumoniaInfections and infestations2/2284/229
Ischaemic strokeNervous system disorders0/2284/229
OsteomyelitisInfections and infestations3/2283/229
Respiratory failureRespiratory, thoracic and mediastinal disorders3/2282/229
Myocardial infarctionCardiac disorders2/2283/229
Most frequent other events
Most frequent other events
EventKSI-301 (Arm A)Aflibercept (Arm B)
COVID-19Infections and infestations32/22834/229
Cataract - Study EyeEye disorders33/22815/229
Diabetic retinal oedema - Fellow EyeEye disorders14/22824/229
HypertensionVascular disorders23/22823/229
Conjunctival haemorrhage - Study EyeEye disorders22/2288/229
Diabetes mellitusMetabolism and nutrition disorders22/22822/229
Cataract - Fellow EyeEye disorders12/22812/229
Diabetic retinal oedema - Study EyeEye disorders12/2284/229

Baseline characteristics

Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.

Age, Categorical
Age, Categorical(Participants)KSI-301 (Arm A)Aflibercept (Arm B)Total
<=18 years000
Between 18 and 65 years133137270
>=65 years9691187
Age, Continuous
Age, Continuous(years)KSI-301 (Arm A)Aflibercept (Arm B)Total
Mean62.2 ± 9.3461.6 ± 9.9061.9 ± 9.62
Sex: Female, Male
Sex: Female, Male(Participants)KSI-301 (Arm A)Aflibercept (Arm B)Total
Female9779176
Male132149281
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)KSI-301 (Arm A)Aflibercept (Arm B)Total
Hispanic or Latino4258100
Not Hispanic or Latino182161343
Unknown or Not Reported5914
Race (NIH/OMB)
Race (NIH/OMB)(Participants)KSI-301 (Arm A)Aflibercept (Arm B)Total
American Indian or Alaska Native011
Asian314
Native Hawaiian or Other Pacific Islander000
Black or African American221234
White194201395
More than one race224
Unknown or Not Reported81119
Geographic Region
Geographic Region(Participants)KSI-301 (Arm A)Aflibercept (Arm B)Total
North America149147296
Rest of World8081161
BCVA in the Study Eye, Letters
BCVA in the Study Eye, Letters(Letters)KSI-301 (Arm A)Aflibercept (Arm B)Total
Mean64.2 ± 11.4364.3 ± 11.2164.2 ± 11.31
08

Study locations

72 sites
  • Retinal Research Institute, LLC
    Phoenix, Arizona 85014, United States
  • Retina Vitreous Associates
    Beverly Hills, California 90211, United States
  • Retina Consultants of Orange County
    Fullerton, California 92835, United States
  • Northern California Retina Vitreous Associates
    Mountain View, California 94040, United States
  • Retina Consultants of San Diego
    Poway, California 92064, United States
  • Retinal Consultants Medical Group Inc
    Sacramento, California 95825, United States
  • Retina Group of New England
    Waterford, Connecticut 06385, United States
  • Florida Eye Microsurgical Institute
    Boynton Beach, Florida 33426, United States
  • Rand Eye Institute
    Deerfield Beach, Florida 33064, United States
  • National Ophthalmic Research Institute
    Fort Myers, Florida 33912, United States
  • Fort Lauderdale Eye Institute
    Plantation, Florida 33324, United States
  • Retina Vitreous Associates of Florida
    Saint Petersburg, Florida 33703, United States
  • Southern Vitreoretinal Associates
    Tallahassee, Florida 32308, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • Georgia Retina, P.C.
    Marietta, Georgia 30060, United States
  • Retina Consultants of Hawaii, Inc
    'Aiea, Hawaii 96701, United States
  • Retina Specialists of Idaho
    Boise, Idaho 83713, United States
  • Talley Eye
    Evansville, Indiana 47710, United States
  • Maine Eye Center
    Portland, Maine 04101, United States
  • Associated Retinal Consultants PC
    Royal Oak, Michigan 48073, United States
  • Vitreoretinal Surgery PA
    Minneapolis, Minnesota 55435, United States
  • Retina Consultants of NV
    Henderson, Nevada 89052, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Vitreo Retinal Consultants
    Hauppauge, New York 11788, United States
  • Retina-Vitreous Surgeons of Central NY
    Liverpool, New York 13088, United States
  • Ophthalmic Consultants of Long Island
    Oceanside, New York 11572, United States
  • Retina Associates of Western NY
    Rochester, New York 14620, United States
  • Asheville Eye Associates
    Asheville, North Carolina 28803, United States
  • Cleveland Clinic Foundation, Cole Eye Institute
    Cleveland, Ohio 44195, United States
  • Retina Consultants, LLC
    Salem, Oregon 97302, United States
  • Southeastern Retina Associates PC
    Knoxville, Tennessee 37922, United States
  • Retina Research Institute of Texas
    Abilene, Texas 79606, United States
  • Austin Research Center for Retina
    Austin, Texas 78705, United States
  • Texas Retina Associates
    Fort Worth, Texas 76108, United States
  • Retina Consultants of Houston-(Katy)
    Katy, Texas 77494, United States
  • Texas Retina Associates
    Plano, Texas 75075, United States
  • Austin Retina Associates (Round Rock)
    Round Rock, Texas 78681, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
  • Retina Consultants of Houston - (Woodlands)
    The Woodlands, Texas 77384, United States
  • Retina Institute of Virginia
    Richmond, Virginia 23235, United States
  • OFTEX s.r.o.
    Pardubice, 53002, Czechia
  • Vseobecna Fakultni
    Praha, 128 08, Czechia
  • Lekarna BENU
    Praha, 150 00, Czechia
  • CHRU Dijon Complexe Du Bocage
    Dijon, Côte-d'Or 21079, France
  • Hôpital de La Croix Rousse
    Lyon, Rhône 69317, France
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94000, France
  • Centre Paradis Monticelli
    Marseille, 13008, France
  • Hôpital Lariboisière - Service Pharmacie , Essais cliniques - Aude Jacob
    Paris, 75 010, France
  • Fondation Rothschild
    Paris, 75019, France
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház
    Nyíregyháza, Szabolcs-Szatmár-Bereg H-4400, Hungary
  • Semmelweis Egyetem
    Budapest, 1085, Hungary
  • Bajcsy-Zsilinszky Korhaz es Rendelointezet
    Budapest, 1106, Hungary
  • Budapest Retina Associates Kft
    Budapest, 1133, Hungary
  • Bnai Zion
    Haifa, 31048, Israel
  • Rambam MC
    Haifa, 31096, Israel
  • Hadassah University Hospital
    Jerusalem, 91120, Israel
  • Meir MC
    Kfar Saba, 44281, Israel
  • Rabin Medical Center
    Petach Tikva, 49100, Israel
  • Kaplan MC
    Rehovot, 76100, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 6423906, Israel
  • Assuta HaShalom
    Tel Aviv, 6789140, Israel
  • Shamir Medical Center Assaf Harofeh
    Tzrifin, 70300, Israel
  • Fondazione Policlinico Universitario A Gemelli
    Roma, Lazio 00168, Italy
  • Ospedale San Raffaele S.r.l. - PPDS
    Milano, Lombardia 20132, Italy
  • AOU dell'Università degli Studi della Campania Luigi Vanvitelli
    Naples, 80131, Italy
  • Optimum Profesorskie Centrum Okulistyki
    Gdansk, Pomorskie 80-809, Poland
  • Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
    Katowice, Slaskie 40-514, Poland
  • Oftalmika Sp. z o.o.
    Bydgoszcz, 85-631, Poland
  • Dr Nowosielska Okulistyka i Chirurgia Oka
    Warszawa, 01-249, Poland
  • Specjalistyczny Szpital im. Alfreda Sokolowskiego
    Wałbrzych, 58-309, Poland
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
    Wrocław, 50-556, Poland
  • Emanuelli Research & Development Center LLC
    Arecibo, 00612, Puerto Rico
09

References and documents

Study documents

  • Study protocol · Mar 15, 2022
  • Statistical analysis plan · Jun 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04603937
Lead sponsor
Kodiak Sciences Inc
Responsible party
Sponsor
First posted
Oct 27, 2020
Start date
Sep 30, 2020
Primary completion
Apr 27, 2023
Completion
Aug 31, 2023
Results posted
Aug 22, 2024
Last update
Aug 22, 2024

Study contacts

Pablo Velazquez-Martin, MD
study director · Kodiak Sciences Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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