Study of Intravitreal KSI-301 in Patients With Neovascular (Wet) Agerelated Macular Degeneratio

Phase 1

Conditions: eovascular (Wet) Age-related Macular Degeneration
MedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2018-003428-35-IT

Lead Sponsor: Kodiak Sciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 368

Inclusion Criteria

1.Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferation (RAP) lesions with a CNV component that affect the central subfield as evidenced by FA or OCT in the Study Eye at Screening.
2.The CNV area in the Study Eye must be at least 50% of total lesion size at Screening.
3.A lesion area <30 mm2 (12 disc areas) of any CNV lesion subtype in the Study Eye.
4.Intra and/or subretinal fluid and/or SHRM (subretinal hyperreflective material) affecting the central subfield of the Study Eye on OCT at Screening.
5.BCVA ETDRS score between 80 and 25 letters (20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye at Screening and reconfirmed at Day 1.
6.Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wet AMD.
7.Only one eye per subject is eligible to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 331

Exclusion Criteria

1.BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
2.Active ocular or periocular infection or inflammation in either eye at Day 1.
3.CNV secondary to other causes in the Study Eye, including pathologic myopia, angioid streaks, prior trauma, ocular histoplasmosis, or others.
4.Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid, such as central serous chorioretinopathy.
5.Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center of the Study Eye at Screening
6.Subretinal blood affecting the foveal center of the Study Eye and/or more than 50% of the lesion size at Screening.
7.Any approved or investigational treatment for neovascular AMD (other than oral vitamin supplements) in the Study Eye at any time.
8.Prior macular laser (e.g., thermal laser or photodynamic therapy laser) in the Study Eye.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in BCVA from Day 1 to Year 1. Year 1 is defined as the mean of the Week 48 and 52 measurements.;Secondary Objective: •To evaluate the efficacy of KSI-301 5 mg compared to aflibercept 2 mg over the study duration of 96 weeks by assessing visual and anatomical parameters.<br>•To evaluate the proportion of subjects maintained on a Q12W, Q16W, or Q20W dosing regimen of KSI-301 over the duration of the first 52 weeks.<br>•To evaluate the safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg.<br>•To assess the systemic pharmacokinetics and immunogenicity of KSI-301.;Primary end point(s): The primary endpoint of this study will be the mean change in BCVA from Day 1 to Year 1, comparing subjects receiving KSI-301 to aflibercept at a non-inferiority margin of 4 letters. Year 1 is defined as the mean BCVA at Weeks 48 and 52.;Timepoint(s) of evaluation of this end point: weeks 48 and 52

Secondary Outcome Measures

Name	Time	Method

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