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Macular DegenerationPhase 3XPLORENCT03805100

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

A Phase 3 study testing Ranibizumab in people with Macular Degeneration, run by Xbrane Biopharma AB at 102 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
582 participants
Where
102 sitesin 15 countries
Study dates
19 Apr 2019to 11 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.
  • Retinal pigment epithelial tear or rip, involving the macula in the study eye as assessed by FA and confirmed by the central reading center.
  • Current vitreous hemorrhage in the study eye.
  • Subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA (≥ 2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center.
  • Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is allowed not later than 4 weeks prior to screening.
  • Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity.
  • Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT).
  • Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation.
  • Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye (as judged by the investigator).
  • History of glaucoma filtering surgery or argon laser trabeculoplasty in the study eye (Exception: Laser iridotomy and selective laser trabeculoplasty are allowed).
  • Uncontrolled ocular glaucoma or hypertension in the study eye, defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication.
  • Any previous systemic anti-VEGF treatment (eg, bevacizumab).
  • Contraindication for Lucentis® (hypersensitivity to ranibizumab or to any of the study treatment excipients).
  • Current treatment for active systemic infection.
  • Females who are pregnant, nursing, planning a pregnancy during the study, or of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study.
  • Participation in another clinical trial within the previous 3 months or any other clinical trial of anti-angiogenic drugs.
  • Reasonable suspicion of other disease or condition that might render the subject at a high risk of treatment complications or otherwise confound interpretation of the study results (as judged by the investigator).
  • PK subgroup only: Contraindication for additional blood sampling (as judged by the investigator).

Trial locations and contacts

102 sites in 15 countries.

102 sites in 15 countries

United States26 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Win Retina

    Arcadia, California, 91006-3607

  • Southeast Retina Center

    Augusta, Georgia, 30909-6440

  • Austin Retina Associates

    Austin, Texas, 78705-1169

  • Gailey Eye Clinic

    Bloomington, Illinois, 61704

  • The Retina Partners

    Encino, California, 91436-2018

  • Fort Lauderdale Eye Institute

    Fort Lauderdale, Florida, 33324-3118

  • Retinal Research Institute, LLC

    Gilbert, Arizona, 85296

  • Mark B. Kislinger MD Inc.

    Glendora, California, 91741

  • Colorado Retina Associates

    Golden, Colorado, 80401-5069

  • Houston Eye Associates

    Houston, Texas, 77025-1756

  • Retina Consultants of Houston

    Houston, Texas, 77030-2727

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Sabates Eye Centers

    Leawood, Kansas, 66211

  • Georgia Retina

    Marietta, Georgia, 30060

  • Retina Vitreous Surgeons of Central New York PC

    New York, New York, 13224

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85021-8880

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Associates of Western New York

    Rochester, New York, 14620-4655

  • Retina Consultants Medical Group Inc.

    Sacramento, California, 95819

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240-1502

  • Sarasota Retina Institute

    Sarasota, Florida, 34239-7246

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Centers P.C

    Tucson, Arizona, 85704-5611

  • Strategic Clinical Research Group LLC

    Willow Park, Texas, 76087

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880-3919

Other trials in United States

Spain14 sites

  • Hospital General Universitario de Albacete

    Albacete, 2006

  • Instituto de Microcirugia Ocular

    Barcelona, 8035

  • Hospital de Viladecans

    Barcelona, 8840

  • Bellvitge University Hospital

    L'Hospitalet de Llobregat, 8907

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Madrid, 02008

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Clinica Universidad de Navarr

    Pamplona, 31008

  • Hospital General de Catalunya

    Sant Cugat del Vallès, 08195

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Unit of Macula. Oftalvist Clinic

    Valencia, 46004

  • FISABIO-Oftalmologia Medica FOM

    Valencia, 46015

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Hungary11 sites

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Department of Ophthalmology, Semmelweis University

    Budapest, 1085

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Szent Imre Teaching Hospital

    Budapest, 1115

  • Budapest Retina Associates

    Budapest, 1133

  • Jahn Ferenc South-Budapest Hospital

    Budapest, 1204

  • University of Debrecen

    Debrecen, 4032

  • Szabolcs-Szatmr-Bereg County Hospital

    Nyíregyháza, 4400

  • Ganglion Medical Center

    Pécs, 7621

  • Markusovszky University Teaching Hospital

    Szombathely, 9700

  • Zalan Megyei Szent Rafael kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Israel11 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 7610001

  • The Tel Aviv Sourasky Medical Centre

    Tel Aviv, 64239

  • Asaf Harofe Hospital

    Zrifin, 73000

Other trials in Israel

Poland6 sites

  • Klinika Okulistyczna Oftalmika

    Bydgoszcz, 85631

  • Professor K. Gibinski University Clinical Centre

    Katowice, 40514

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20079

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10424

  • Dr Nowosielska Okulistyka i Chirurgia Oka

    Warsaw, 01249

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

    Warsaw, 01364

Other trials in Poland

Russia6 sites

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

    Cheboksary, 428028

  • LLC Kuzlyar

    Kazan', 420066

  • Federal State Budget Scientific Institute of Eye Diseases

    Moscow, 119021

  • S. Fyodorov Eye Microsurgery Federal State Institution

    Moscow, 127486

  • S.Fyodorov Eye Microsurgery Federal State Institution

    Saint Petersburg, 192283

  • First Pavlov State Medical University of St.Petersburg

    Saint Petersburg, 197022

Other trials in Russia

Bulgaria5 sites

  • Specialized Eye hospital for active treatment Luxor

    Plovdiv, 4000

  • Specialized eye clinic Zrenie

    Sofia, 1408

  • Specialized Eye hospital for active treatment Acad. Pashev

    Sofia, 1517

  • Specialized Hospital for Active Treatment of Eye Diseases "Zora"

    Sofia, 1744

  • AMCSMP Eye Clinic St. Petka

    Varna, 9010

Other trials in Bulgaria

Czechia5 sites

  • Všeobecná FN v Praze

    Brno, 625 00

  • Oční klinika, Fakultní nemocnice

    Hradec Králové, 50005

  • Faculty Hospital Kralovske Vinohrady

    Prague, 10034

  • VFN Ocni klinika

    Prague, 12808

  • Axon-Clinical, s.r.o.

    Prague, 15000

Other trials in Czechia

Ukraine5 sites

  • Regional Clinical Hospital Center for Emergency Medical Care And Disaster Medicine

    Kharkiv, 61204

  • Medical and Diagnostic Centre PE PMC "Acinus"

    Kropyvnytskyi, 25006

  • Filatov Institute of Eye Diseases Tissue Therapy

    Odesa, 65061

  • Clinic of Professor Serhiienko

    Vinnitsa, 21000

  • Medical center LTD VISUS

    Zaporizhzhya, 69032

Other trials in Ukraine

Slovakia4 sites

  • F.D.Roosevelt Hospital

    Banská Bystrica, 97517

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • Fakultna nemocnica Trencin

    Trenčín, 91171

  • Fakultna nemocnica s poliklinikou Zilina

    Žilina, 1207

Other trials in Slovakia

Estonia2 sites

  • OÜ Dr Kai Noor Silmakabinet

    Tallinn, 11412

  • Mustame Eye Centre

    Tallinn, 13419

Other trials in Estonia

Latvia2 sites

  • P.Stradins University Hospital

    Riga, 1002

  • The Dr Solomatin Eye Center

    Riga, 1050

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661

Other trials in Lithuania

Romania2 sites

  • Clinica Retina

    Bucharest, 014142

  • Opticlass Timisoara

    Timișoara, 300012

Other trials in Romania

India1 site

  • Rising Retina Clinic

    Ahmedabad, 380015

Other trials in India

About this study

Official title: 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

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).

Read the 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.

Being tested
Ranibizumab
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03805100
Study groupRoleWhat they receive
XlucaneExperimentalXlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.
Receives: Biological: Ranibizumab
LucentisActive comparatorLucentis (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.
Receives: Biological: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Best Corrected Visual Acuity (BCVA)

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

    Measured: Baseline and Week 8

Secondary outcomes (9)

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

    Change in the total size of choroidal neovascular leakage area in the study eye week 52 compared to baseline measured by Fluorescein Angiography

    Measured: Baseline and Week 52

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

    Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye Measured by Fluorescein Angiography

    Measured: Baseline and week 52

  3. Central Foveal Thickness in the Study Eye

    Central Foveal Thickness in the Study Eye Measured by Optical Coherence Tomography

    Measured: Baseline to week 52

  4. Percentage of Subjects With Loss of <15 BCVA Letters

    Percentage of Subjects With Loss of <15 BCVA Letters Compared to Baseline in the Study Eye

    Measured: Baseline to week 52

  5. Percentage of Subjects With Gain of ≥15 BCVA Letters

    Percentage of Subjects With Gain of ≥15 BCVA Letters Compared to Baseline in the Study Eye

    Measured: Baseline to week 52

  6. Subretinal Fluid in the Study Eye

    Change from Baseline in the Amount of Subretinal Fluid in the Study Eye Measured by OCT

    Measured: Baseline to week 52

  7. Width of Retinal Pigment Epithelium Detachments in the Study Eye

    Change from Baseline in the Width of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT

    Measured: Baseline to Week 52

  8. Pharmacokinetic Plasma Ranibizumab Concentrations

    Pharmacokinetic Plasma Ranibizumab Concentrations (sub-study)

    Measured: Day 1 to week 20

  9. Height of Retinal Pigment Epithelium Detachments

    Change from Baseline in the Height of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start19 Apr 2019
  3. Primary completion11 May 2021
  4. Study completion11 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
582 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805100
Sponsor's protocol ID
XBR1001
Acronym
XPLORE
Status last verified
Feb 2023
First submitted
8 Jan 2019
Last updated
13 Nov 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranibizumab in people with Macular Degeneration, run by Xbrane Biopharma AB at 102 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Spain, Hungary, Israel, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Best Corrected Visual Acuity (BCVA) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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