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Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD | Clinical Trials | Clareo Health

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Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis® in Patients With Neovascular Age-Related Macular Degeneration

NCT03805100•Xbrane Biopharma AB

View on ClinicalTrials.gov

Summary

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Detailed Description

This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis® or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written and signed informed consent form obtained at screening, before any study-related procedures.
•Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator.
•Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be confirmed by the central reading center during Screening:
•1. The area of CNV must be ≥ 50% of the total lesion area in the study eye, and
•2. Total lesion area ≤ 9.0 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye.
•Best Corrected Visual Acuity (BCVA) of ≤ 73 and ≥ 49 ETDRS letter score in the study eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening.
•Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation.
•Age ≥ 50 years at screening.
•Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug.

Exclusion Criteria

•Any previous intervention including pharmacological treatment, laser and/or surgery for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention).
•Any previous vitreoretinal surgery in the study eye for any cause.
•Any previous IVT treatment including any anti-VEGF medications, steroids and/or any other investigational medication in either eye.
•The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Iluvien® \[fluocinolone acetonide intravitreal\], current or planned implantation during the study, is prohibited.)
•Subfoveal fibrosis, atrophy or scarring extending \> 50% of total lesion area, in the study eye as assessed by the investigator at screening and confirmed by the central reading center prior to randomization.
•Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading center.
•Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye.
•History of idiopathic or autoimmune-associated uveitis in either eye.
•Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
•Unmedicated intraocular pressure (IOP) ≥ 30 mmHg at Screening in either eye.
+22 more criteria

Locations (102)

Retinal Research Institute, LLC

Gilbert, Arizona, United States

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Retina Centers P.C

Tucson, Arizona, United States

Win Retina

Arcadia, California, United States

The Retina Partners

Encino, California, United States

Mark B. Kislinger MD Inc.

Glendora, California, United States

Retina Consultants Medical Group Inc.

Sacramento, California, United States

Colorado Retina Associates

Golden, Colorado, United States

Fort Lauderdale Eye Institute

Fort Lauderdale, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Key Dates

Start Date

April 19, 2019

Primary Completion Date

May 11, 2021

Completion Date

November 11, 2021

Last Updated

November 13, 2023

Enrollment

582

ACTUAL participants

Conditions

Macular Degeneration

Interventions

Ranibizumab

BIOLOGICAL

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

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RECRUITING

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

NCT07446582

Age-Related (Dry) Macular Degeneration

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RECRUITING

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration