Trial Search Results

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Kodiak Sciences Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: KSI-301
  • Drug: Aflibercept
  • Other: Sham Procedure

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Signed informed consent prior to participation in the study.

   2. Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO.
   Participants with hemiretinal vein occlusion will be included as CRVO.

   3. BCVA ETDRS letter score between 80 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 ME
   secondary to RVO.

   6. Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

   1. Macular edema in the Study Eye for reasons other than RVO

   2. Active iris or angle neovascularization, neovascular glaucoma, neovascularization of
   the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.

   3. Uncontrolled glaucoma in the Study Eye.

   4. Active retinal disease other than the condition under investigation in the Study Eye.

   5. Any history or evidence of a concurrent ocular condition present, that in the opinion
   of the Investigator could require either medical or surgical intervention alter visual
   acuity during the study

   6. Active or suspected ocular or periocular infection or inflammation

   7. Any prior use of an approved or investigational treatment for macular edema secondary
   to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular
   laser photocoagulation).

   8. Women who are pregnant or lactating or intending to become pregnant during the study.

   9. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value
   ≥100 mmHg while at rest

10. 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.

11. 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.

12. Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

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