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 | Terminated Phase 1 FDA Drug

• 1 other identifier: KSI-CL-101
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 11

Brief 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

Keywords

DME; wAMD; RVO; KSI-301; Kodiak

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-301 DRUG

Intravitreal injection

KSI-301 2.5 mg; KSI-301 5 mg

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
• Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.
• DME Cohort
• Treatment naïve diabetic macular edema.
• BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
• Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
• Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
• RVO Cohort
• Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.
• BCVA ETDRS letter score ≤ 78 and ≥ 23 (-20/25 to -20/320 Snellen equivalent) in the study eye.
• Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
• Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible.

You may not qualify if:

• Wet AMD Cohort:
• Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
• Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
• Prior intravitreal anti-VEGF therapy in the study eye.
• DME Cohort:
• Initial diagnosis of DME of more than 6 months from screening in the study eye.
• Hard exudates in the fovea.
• Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
• Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
• Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.
• RVO Cohort:
• Initial diagnosis of RVO of more than 4 months from screening in the study eye.
• Active retinal or iris neovascularization in the study eye.
• Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
• For all phase 1b subjects:

Sponsors & Collaborators

• Kodiak Sciences Inc: lead

Study Sites (11)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Clinical Research

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas Woodlands

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pablo Velazquez-Martin, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

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
• Primary Completion: June 2, 2021
• Study Completion: June 9, 2022
• Last Updated: March 20, 2024

Record last verified: 2022-11

Locations

US (11)