Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

DMEwAMDRVOKSI-301Kodiak

Outcome Measures

Primary Outcomes (1)

Incidence of ocular (study eye) and systemic adverse events
Week 72

Other Outcomes (2)

Mean change in central retinal thickness on optical coherence tomography
Baseline, Week 72
Mean change in best corrected visual acuity
Baseline, Week 72

Study Arms (2)

KSI-301 2.5 mg

EXPERIMENTAL

KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria

Drug: KSI-301

KSI-301 5 mg

EXPERIMENTAL

KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria

Drug: KSI-301

Interventions

KSI-301Drug

Intravitreal injection

KSI-301 2.5 mgKSI-301 5 mg

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Wet AMD Cohort
Treatment naïve wet age-related macular degeneration involving the fovea.

Sponsors & Collaborators

Kodiak Sciences Inc
Industrylead

Study Sites (11)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Sierra Eye Associates

Reno, Nevada, 89502, United States

Mid Atlantic Retina

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

Pablo Velazquez-Martin, MD
Kodiak Sciences Inc
STUDY DIRECTOR

Enrollment

121 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

January 2, 2019

Study Start

December 26, 2018

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (2)

KSI-301 2.5 mg

KSI-301 5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (2)

KSI-301 2.5 mg

KSI-301 5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations