A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration

Kyowa Kirin

Status and phase

Terminated

Phase 1

Conditions

Wet Age-related Macular Degeneration

Healthy Volunteers

Treatments

Drug: Placebo

Drug: KHK4951

Study type

Interventional

Funder types

Industry

Identifiers

NCT04594681

4951-001

Details and patient eligibility

About

The purpose of this study is to evaluate safety and tolerability after administration of KHK4951 in healthy volunteers and patients with wet age-related macular degeneration.

Enrollment

116 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Healthy Volunteers

Voluntary written informed consent to participate in the study
Japanese or white men 20 to < 50 years at the time of informed consent
BMI 18.5 to < 30.0 at screening
Intraocular pressure (study eye) 10.0 mm Hg to 21.0 mm Hg
Monocular or binocular visual acuity (corrected visual acuity if correction is required) ≥ 1.0 at screening

Inclusion Criteria: Patients

Voluntary written informed consent to participate in the study
Age ≥ 50 years at the time of informed consent
AMD-associated by active subfoveal CNV lesions in the study eye or juxtafoveal CNV lesions with CNV-associated findings in the fovea in the study eye
CST ≥ 300 μm in the study eye at screening, as measured by OCT
BCVA score ≥ 23 letters in the study eye at screening and enrollment, as measured by the ETDRS visual acuity chart
BCVA score ≥ 58 letters in the non-study eye at screening, as measured by the ETDRS visual acuity chart
In subjects with prior treatment of the study eye with anti-vascular endothelial growth factor (anti-VEGF) drugs such as Beovu, Eylea, Lucentis, Avastin, or Macugen, presence of response to the anti-VEGF drug(s) as judged by the investigator or subinvestigator based OCT, FA, visual acuity, or other assessment results

Exclusion Criteria: Healthy Volunteers

Current illness requiring treatment
History of ophthalmologic laser surgery, ophthalmologic surgery, nasolacrimal duct surgery, orany eyelid surgery affecting flow in the nasolacrimal duct
History of or current circulatory disease (e.g., cerebrovascular or cardiovascular disease)
History of or current dry eye
Abnormal findings on OCT at screening or enrollment examination

Exclusion Criteria: Patients

Clinical findings or a history of conditions other than wAMD affecting the retina and choroid (e.g., diabetic retinopathy, diabetic macular edema, myopic CNV, retinal vein occlusion, or premacular membrane) in either of the eyes
Any of the following diseases in the study eye:
- Glaucoma
- Ischemic optic neuropathy
- Retinitis pigmentosa
Current or history of vitreous hemorrhage or macular hole in the study eye
Any abnormality in the anterior segment of the eye or vitreous body that may affect fundus observation by OCT, color fundus photography, or fluorescein angiography