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A 3-month Study to Assess the...

A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)

NCT ID: NCT06190093

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2024-12-05

Brief Summary

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Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.

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Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration Age-Related Macular Degeneration Wet Macular Degeneration

Study Design

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Allocation Method

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ONS-5010 bevacizumab

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

1.25 mg, intravitreal injection

ranibizumab

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type BIOLOGICAL

0.5mg, intravitreal injection

Interventions

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bevacizumab

1.25 mg, intravitreal injection

Intervention Type BIOLOGICAL

ranibizumab

0.5mg, intravitreal injection

Intervention Type BIOLOGICAL

Other Intervention Names

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ONS-5010

Eligibility Criteria

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Inclusion Criteria

* Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
* Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)
* Study eye must:
* Have active leakage on Fluorescein Angiogram involving the fovea
* Have edema involving the fovea
* Be free of scarring, fibrosis, or atrophy involving the central foveal zone

Exclusion Criteria

* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers