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

NCT03805100 | Completed Phase 3 Results FDA Drug

• 1 other identifier: XBR1001
• Study Type: interventional
• Target: 582
• Locations: 14 countries
• Sites: 100

Brief 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).

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change in Best Corrected Visual Acuity (BCVA)

  Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol

  Baseline and Week 8

Secondary Outcomes (9)

• Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye

  Baseline and Week 52

• Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye

  Baseline and week 52

• Central Foveal Thickness in the Study Eye

  Baseline to week 52

• Percentage of Subjects With Loss of <15 BCVA Letters

  Baseline to week 52

• Percentage of Subjects With Gain of ≥15 BCVA Letters

  Baseline to week 52

Study Arms (2)

Xlucane

EXPERIMENTAL

Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.

Biological: Ranibizumab

Lucentis

ACTIVE COMPARATOR

Lucentis (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.

Biological: Ranibizumab

Interventions

Ranibizumab BIOLOGICAL

Intravitreal injection

Lucentis; Xlucane

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• The area of CNV must be ≥ 50% of the total lesion area in the study eye, and
• 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.

You may not qualify if:

• 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.
• Topical ocular corticosteroids administered for ≥ 30 consecutive days in the study eye within 90 days prior to Screening.
• Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia.
• Corneal transplant or corneal dystrophy in the study eye.
• History of rhegmatogenous retinal detachment in the study eye.
• History of macular hole in the study eye.

Sponsors & Collaborators

• Xbrane Biopharma AB: lead
• Stada Arzneimittel AG: collaborator

Study Sites (102)

Retinal Research Institute, LLC

Gilbert, Arizona, 85296, United States

Location

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85021-8880, United States

Location

Retina Centers P.C

Tucson, Arizona, 85704-5611, United States

Location

Win Retina

Arcadia, California, 91006-3607, United States

Location

The Retina Partners

Encino, California, 91436-2018, United States

Location

Mark B. Kislinger MD Inc.

Glendora, California, 91741, United States

Location

Retina Consultants Medical Group Inc.

Sacramento, California, 95819, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401-5069, United States

Location

Fort Lauderdale Eye Institute

Fort Lauderdale, Florida, 33324-3118, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239-7246, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880-3919, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909-6440, United States

Location

Georgia Retina

Marietta, Georgia, 30060, United States

Location

Gailey Eye Clinic

Bloomington, Illinois, 61704, United States

Location

Sabates Eye Centers

Leawood, Kansas, 66211, United States

Location

Retina Vitreous Surgeons of Central New York PC

New York, New York, 13224, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620-4655, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705-1169, United States

Location

Houston Eye Associates

Houston, Texas, 77025-1756, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030-2727, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240-1502, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group LLC

Willow Park, Texas, 76087, United States

Location

Specialized Eye hospital for active treatment Luxor

Plovdiv, 4000, Bulgaria

Location

Specialized eye clinic Zrenie

Sofia, 1408, Bulgaria

Location

Specialized Eye hospital for active treatment Acad. Pashev

Sofia, 1517, Bulgaria

Location

Specialized Hospital for Active Treatment of Eye Diseases "Zora"

Sofia, 1744, Bulgaria

Location

AMCSMP Eye Clinic St. Petka

Varna, 9010, Bulgaria

Location

Všeobecná FN v Praze

Brno, 625 00, Czechia

Location

Oční klinika, Fakultní nemocnice

Hradec Králové, 50005, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

VFN Ocni klinika

Prague, 12808, Czechia

Location

Axon-Clinical, s.r.o.

Prague, 15000, Czechia

Location

OÜ Dr Kai Noor Silmakabinet

Tallinn, 11412, Estonia

Location

Mustame Eye Centre

Tallinn, 13419, Estonia

Location

Magyar Honvédség Egészségügyi Központ

Budapest, 1062, Hungary

Location

Department of Ophthalmology, Semmelweis University

Budapest, 1085, Hungary

Location

Bajcsy-Zsilinszky Hospital

Budapest, 1106, Hungary

Location

Szent Imre Teaching Hospital

Budapest, 1115, Hungary

Location

Budapest Retina Associates

Budapest, 1133, Hungary

Location

Jahn Ferenc South-Budapest Hospital

Budapest, 1204, Hungary

Location

University of Debrecen

Debrecen, 4032, Hungary

Location

Szabolcs-Szatmr-Bereg County Hospital

Nyíregyháza, 4400, Hungary

Location

Ganglion Medical Center

Pécs, 7621, Hungary

Location

Markusovszky University Teaching Hospital

Szombathely, 9700, Hungary

Location

Zalan Megyei Szent Rafael kórház

Zalaegerszeg, 8900, Hungary

Location

Rising Retina Clinic

Ahmedabad, 380015, India

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 7610001, Israel

Location

The Tel Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

Location

Asaf Harofe Hospital

Zrifin, 73000, Israel

Location

P.Stradins University Hospital

Riga, 1002, Latvia

Location

The Dr Solomatin Eye Center

Riga, 1050, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Klinika Okulistyczna Oftalmika

Bydgoszcz, 85631, Poland

Location

Professor K. Gibinski University Clinical Centre

Katowice, 40514, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

Lublin, 20079, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10424, Poland

Location

Dr Nowosielska Okulistyka i Chirurgia Oka

Warsaw, 01249, Poland

Location

Retina Okulistyka Sp. z o.o. sp. km

Warsaw, 01364, Poland

Location

Clinica Retina

Bucharest, 014142, Romania

Location

Opticlass Timisoara

Timișoara, 300012, Romania

Location

FGAU NMRC MNTK Eye Microsurgery n.a. acad. S.N. Fyodorov Cheboksary Branch

Cheboksary, 428028, Russia

Location

LLC Kuzlyar

Kazan', 420066, Russia

Location

Federal State Budget Scientific Institute of Eye Diseases

Moscow, 119021, Russia

Location

S. Fyodorov Eye Microsurgery Federal State Institution

Moscow, 127486, Russia

Location

S.Fyodorov Eye Microsurgery Federal State Institution

Saint Petersburg, 192283, Russia

Location

First Pavlov State Medical University of St.Petersburg

Saint Petersburg, 197022, Russia

Location

F.D.Roosevelt Hospital

Banská Bystrica, 97517, Slovakia

Location

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, 82606, Slovakia

Location

Fakultna nemocnica Trencin

Trenčín, 91171, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina

Žilina, 1207, Slovakia

Location

Hospital General Universitario de Albacete

Albacete, 2006, Spain

Location

Instituto de Microcirugia Ocular

Barcelona, 8035, Spain

Location

Hospital de Viladecans

Barcelona, 8840, Spain

Location

Bellvitge University Hospital

L'Hospitalet de Llobregat, 8907, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, 02008, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Clinica Universidad de Navarr

Pamplona, 31008, Spain

Location

Hospital General de Catalunya

Sant Cugat del Vallès, 08195, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Unit of Macula. Oftalvist Clinic

Valencia, 46004, Spain

Location

FISABIO-Oftalmologia Medica FOM

Valencia, 46015, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Regional Clinical Hospital Center for Emergency Medical Care And Disaster Medicine

Kharkiv, 61204, Ukraine

Location

Medical and Diagnostic Centre PE PMC "Acinus"

Kropyvnytskyi, 25006, Ukraine

Location

Filatov Institute of Eye Diseases Tissue Therapy

Odesa, 65061, Ukraine

Location

Clinic of Professor Serhiienko

Vinnitsa, 21000, Ukraine

Location

Medical center LTD VISUS

Zaporizhzhia, 69032, Ukraine

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Affairs
• Organization: Xbrane Biopharma AB

xbregistry@xbrane.com

+46 85-590 56 00

Study Officials

• Anat Loewenstein, Professor

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 15, 2019
• Study Start: April 19, 2019
• Primary Completion: May 11, 2021
• Study Completion: November 11, 2021
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); RO (2); CZ (5); RU (6); PL (6); ES (14); SL (4); LI (2); IN (1); IL (11); BU (5); UA (5); LA (2); HU (11)