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


Trial ID: NCT04611152


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

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 Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

Stanford Investigator(s)

Steven Sanislo, MD
Steven Sanislo, MD

Clinical Professor, Ophthalmology


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:

   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.


drug: KSI-301

drug: Aflibercept

other: Sham Procedure


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305