Diabetic Retinopathy
Conditions
Keywords
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, Tarcocimab Tedromer, Tarcocimab, Diabetic Eye Disease
Brief summary
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.
Detailed description
This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.
Interventions
DRUGTarcocimab
Intravitreal injection
OTHERSham injection
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.
Sponsors
Kodiak Sciences Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments.
Intervention model description
Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent prior to participation in the study. * Type 1 or 2 diabetes mellitus and HbA1c of ≤12%. * DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator. * CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR * CST \>320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.
Exclusion criteria
* 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 within the last twelve (12) months prior to Day 1. * Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1. * Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye. * History of vitreoretinal surgery in the Study Eye. * History of uveitis in either eye. * Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening. * Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) | Day 1 to Week 48 | Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy | Day 1 to Week 48 | Sight-threatening complications include diabetic macular edema, new or worsening proliferative diabetic retinopathy, and anterior segment neovascularization |
| Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) | Day 1 to Week 48 | Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes. |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORPablo Velazquez-Martin, MD
Kodiak Sciences Inc
Outcome results
None listed