Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Kodiak Sciences Inc
No Placebo Group
Trial Summary
What is the purpose of this trial?
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg
Research Team
PV
Pablo Velazquez-Martin, MD
Principal Investigator
Kodiak Sciences Inc
Eligibility Criteria
Inclusion Criteria
Wet AMD Cohort
Treatment naïve wet age-related macular degeneration involving the fovea.
A lesion area <30 mm2 (12 disc areas) of any lesion type.
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Treatment Details
Interventions
- KSI-301 (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: KSI-301 5 mgExperimental Treatment1 Intervention
KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
Group II: KSI-301 2.5 mgExperimental Treatment1 Intervention
KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
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Who Is Running the Clinical Trial?
Kodiak Sciences Inc
Lead Sponsor
Trials
9
Recruited
3,900+