NCT03805100 (XPLORE) is a Phase 3 clinical trial of Ranibizumab in Macular Degeneration, sponsored by Xbrane Biopharma AB.

Who is sponsoring NCT03805100?

NCT03805100 is sponsored by Xbrane Biopharma AB.

What drugs are being tested in NCT03805100?

Interventions in NCT03805100: Ranibizumab.

What condition does NCT03805100 study?

NCT03805100 studies Macular Degeneration.

Is NCT03805100 still recruiting?

NCT03805100 is currently completed. Last updated 13 November 2023.

Are results published for NCT03805100?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-13 · How we verify

NCT03805100: XPLORE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 13 November 2023

What this trial tests

Phase 3 trial testing Ranibizumab in Macular Degeneration in 582 participants. Completed in 11 November 2021.

Timeline

19 April 2019

Primary endpoint
11 May 2021

11 November 2021

Quick facts

Lead sponsor	Xbrane Biopharma AB
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	582
Start date	19 April 2019
Primary completion	11 May 2021
Estimated completion	11 November 2021
Sites	102 locations across Slovakia, Russia, Ukraine, India, Estonia, Israel, Hungary, Poland

Drugs / interventions tested

Ranibizumab — full drug profile →

Conditions studied

Macular Degeneration — all drugs for Macular Degeneration →

Sponsor

Xbrane Biopharma AB

Who can join

50 and older, any sex, with Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Best Corrected Visual Acuity (BCVA) Primary · Baseline and Week 8

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	4.57	3.54 – 5.61
Lucentis (Ranibizumab)	6.37	5.31 – 7.42

Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye Secondary · Baseline and Week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-4.09	-4.66 – -3.52
Lucentis (Ranibizumab)	-3.71	-4.28 – -3.14

Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye Secondary · Baseline and week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-1.62	-2.19 – -1.05
Lucentis (Ranibizumab)	-1.11	-1.68 – -0.54

Central Foveal Thickness in the Study Eye Secondary · Baseline to week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-117.44	-125.33 – 109.55
Lucentis (Ranibizumab)	-115.14	-123.14 – -107.14

Percentage of Subjects With Loss of <15 BCVA Letters Secondary · Baseline to week 52

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

Missing at random (MAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	94.8
Lucentis (Ranibizumab)	96.0

Missing completely at random (MCAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	94.9
Lucentis (Ranibizumab)	96.1

Missing not at random (MNAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	94.8
Lucentis (Ranibizumab)	96.1

Composite (Missing and non-evaluable data are classed as no response)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	68.8
Lucentis (Ranibizumab)	67.6

Percentage of Subjects With Gain of ≥15 BCVA Letters Secondary · Baseline to week 52

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

Missing at random (MAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	23.6
Lucentis (Ranibizumab)	29.7

Missing completely at random (MCAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	23.2
Lucentis (Ranibizumab)	28.8

Missing not at random (MNAR)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	23.6
Lucentis (Ranibizumab)	30.4

Composite (Missing and non-evaluable data are classed as no response)

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	17.1
Lucentis (Ranibizumab)	21.4

Subretinal Fluid in the Study Eye Secondary · Baseline to week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-34.88	-39.07 – -30.69
Lucentis (Ranibizumab)	-32.93	-37.21 – -28.65

Width of Retinal Pigment Epithelium Detachments in the Study Eye Secondary · Baseline to Week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-161.39	-387.16 – -135.62
Lucentis (Ranibizumab)	-256.33	-384.56 – -128.10

Pharmacokinetic Plasma Ranibizumab Concentrations Secondary · Day 1 to week 20

Pharmacokinetic Plasma Ranibizumab Concentrations (sub-study)

Day 1

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	2230	± 1429
Lucentis (Ranibizumab)	2190	± 1336

Week 20

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	2450	± 1384
Lucentis (Ranibizumab)	2150	± 1233

Height of Retinal Pigment Epithelium Detachments Secondary · Baseline to Week 52

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

Group	Value	95% CI
Xlucane (Proposed Ranibizumab Biosimilar)	-81.49	-96.33 – -66.66
Lucentis (Ranibizumab)	-73.15	-88.35 – -57.95

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time the participant signed the written informed consent to 28 days [± 5 days] of receiving last dose of study drug, up to 53 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Xlucane (Proposed Ranibizumab Biosimilar)

Serious: 33/292 (11%)

Deaths: 8/292

Lucentis (Ranibizumab)

Serious: 35/290 (12%)

Deaths: 3/290

Serious adverse events (74 terms)

Reaction	System	Xlucane (Proposed Ranibizu…	Lucentis (Ranibizumab)
COVID-19	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Artrial fibrilation	Cardiac disorders	—	—
Myocardial infraction	Cardiac disorders	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—
Retinal pigment epithelial tear	Eye disorders	—	—
Pneumonia	Infections and infestations	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—
Death	General disorders	—	—
Transient ischaemic attack	Nervous system disorders	—	—
Retinal Haemorrhage	Eye disorders	—	—
Macular vasospasm	Eye disorders	—	—
Visual acuity reduced	Eye disorders	—	—
Endophthalmitis	Eye disorders	—	—
Cellulitis	Infections and infestations	—	—
Appendiceal Abscess	Infections and infestations	—	—
COVID-19 pneumonia	Infections and infestations	—	—
Endocarditis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Staphylococcal infection	Infections and infestations	—	—
Cardiac arrest	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Cardiopulmonary failure	Cardiac disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Xlucane (Proposed Ranibizu…	Lucentis (Ranibizumab)
Hypertension	Vascular disorders	—	—
Conjunctival Haemorrhage	Eye disorders	—	—

Most-reported serious reactions: COVID-19, Urinary tract infection, Artrial fibrilation, Myocardial infraction, Humerus fracture, Retinal pigment epithelial tear, Pneumonia, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT03805100 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR BIOSIMILARS IN OPHTHALMOLOGY.
Kaiser PK, Schmitz-Valckenberg MS, Holz FG. · · 2022 · cited 36× · PMID 36394884 · DOI 10.1097/iae.0000000000003626
An update on long-acting therapies in chronic sight-threatening eye diseases of the posterior segment: AMD, DMO, RVO, uveitis and glaucoma.
Ghanchi F, Bourne R, Downes SM, Gale R, et al · · 2022 · cited 35× · PMID 34974541 · DOI 10.1038/s41433-021-01766-w
Initial Experience With Biosimilar Bevacizumab-bvzr For Intravitreal Use in Children: A Case Series and Literature Review.
Jung EE, Lee TC, Nagiel A. · · 2023 · cited 4× · PMID 36780635 · DOI 10.3928/23258160-20230130-01
Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases.
Van de Wiele VL, Hammer M, Parikh R, Feldman WB, et al · · 2022 · cited 3× · PMID 35211322 · DOI 10.1093/jlb/lsac001

Verify or expand the search:

Other trials of Ranibizumab

Trials testing the same drug.

NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
NCT06957080 — A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME · Phase 2, PHASE3 · active not recruiting
NCT06176352 — A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Path · Phase 3 · active not recruiting
NCT05126966 — A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Afl · Phase 3 · withdrawn
NCT05480293 — This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab · Phase 3 · unknown

Other recruiting trials for Macular Degeneration

Currently open trials in the same condition.

NCT07440225 — A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) · Phase 2, PHASE3 · recruiting
NCT07085533 — Natural History Study of Inherited Retinal Diseases · recruiting
NCT06805474 — A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT · recruiting
NCT06779773 — A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy · recruiting
NCT06635148 — A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Se · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03805100 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xbrane Biopharma AB
Last refreshed: 13 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03805100.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing