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
NCT03790852 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2024-03-20
Summary
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
Conditions
- Wet Age-related Macular Degeneration
- Retinal Vein Occlusion
- Diabetic Macular Edema
Interventions
- DRUG
-
KSI-301
Intravitreal injection
Sponsors & Collaborators
-
Kodiak Sciences Inc
lead INDUSTRY
Principal Investigators
-
Pablo Velazquez-Martin, MD · Kodiak Sciences Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-26
- Primary Completion
- 2021-06-02
- Completion
- 2022-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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