Trial · NCT03805100
Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD
NCT03805100, Phase 3, Completed, Xbrane Biopharma AB; results first posted 2023-11-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD. Trials, record NCT03805100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03805100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD
- NCT number
- NCT03805100
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 582 participants, actual
- Lead sponsor
- Xbrane Biopharma AB
- Conditions
- Macular Degeneration
- Interventions
- Ranibizumab
- First posted
- 2019-01-15
- Last updated
- 2023-11-13
- Results first posted
- 2023-11-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best Corrected Visual Acuity (BCVA) | Baseline and Week 8 | Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol |
| Secondary | Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye | 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 |
| Secondary | Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye | Baseline and week 52 | Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye Measured by Fluorescein Angiography |
| Secondary | Central Foveal Thickness in the Study Eye | Baseline to week 52 | Central Foveal Thickness in the Study Eye Measured by Optical Coherence Tomography |
| Secondary | Percentage of Subjects With Loss of <15 BCVA Letters | Baseline to week 52 | Percentage of Subjects With Loss of \<15 BCVA Letters Compared to Baseline in the Study Eye |
| Secondary | Percentage of Subjects With Gain of ≥15 BCVA Letters | Baseline to week 52 | Percentage of Subjects With Gain of ≥15 BCVA Letters Compared to Baseline in the Study Eye |
| Secondary | Subretinal Fluid in the Study Eye | Baseline to week 52 | Change from Baseline in the Amount of Subretinal Fluid in the Study Eye Measured by OCT |
| Secondary | Width of Retinal Pigment Epithelium Detachments in the Study Eye | Baseline to Week 52 | Change from Baseline in the Width of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT |
| Secondary | Pharmacokinetic Plasma Ranibizumab Concentrations | Day 1 to week 20 | Pharmacokinetic Plasma Ranibizumab Concentrations (sub-study) |
| Secondary | Height of Retinal Pigment Epithelium Detachments | Baseline to Week 52 | Change from Baseline in the Height of Retinal Pigment Epithelium Detachments in the Study Eye Measured by OCT |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Best Corrected Visual Acuity (BCVA) | Baseline and Week 8 | Letters | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye | Baseline and Week 52 | mm2 | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye | Baseline and week 52 | mm2 | LEAST_SQUARES_MEAN | |
| SECONDARY | Central Foveal Thickness in the Study Eye | Baseline to week 52 | um | LEAST_SQUARES_MEAN | |
| SECONDARY | Percentage of Subjects With Loss of <15 BCVA Letters | Baseline to week 52 | percentage of responders | NUMBER | |
| SECONDARY | Percentage of Subjects With Gain of ≥15 BCVA Letters | Baseline to week 52 | percentage of responders | NUMBER | |
| SECONDARY | Subretinal Fluid in the Study Eye | Baseline to week 52 | um | LEAST_SQUARES_MEAN | |
| SECONDARY | Width of Retinal Pigment Epithelium Detachments in the Study Eye | Baseline to Week 52 | um | LEAST_SQUARES_MEAN | |
| SECONDARY | Pharmacokinetic Plasma Ranibizumab Concentrations | Day 1 to week 20 | 70 patients were included in the PK substudy | pg/mL | MEAN |
| SECONDARY | Height of Retinal Pigment Epithelium Detachments | Baseline to Week 52 | um | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) | Xlucane (Proposed Ranibizumab Biosimilar) | 4.57 | 95% Confidence Interval 3.54 to 5.61 | Letters | |
| Change in Best Corrected Visual Acuity (BCVA) | Lucentis (Ranibizumab) | 6.37 | 95% Confidence Interval 5.31 to 7.42 | Letters | |
| Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye | Xlucane (Proposed Ranibizumab Biosimilar) | -4.09 | 95% Confidence Interval -4.66 to -3.52 | mm2 | |
| Change From Baseline in the Total Size of Choroidal Neovascular Leakage Area in the Study Eye | Lucentis (Ranibizumab) | -3.71 | 95% Confidence Interval -4.28 to -3.14 | mm2 | |
| Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye | Xlucane (Proposed Ranibizumab Biosimilar) | -1.62 | 95% Confidence Interval -2.19 to -1.05 | mm2 | |
| Change From Baseline in the Total Size of Choroidal Neovascularisation in the Study Eye | Lucentis (Ranibizumab) | -1.11 | 95% Confidence Interval -1.68 to -0.54 | mm2 | |
| Central Foveal Thickness in the Study Eye | Xlucane (Proposed Ranibizumab Biosimilar) | -117.44 | 95% Confidence Interval -125.33 to 109.55 | um | |
| Central Foveal Thickness in the Study Eye | Lucentis (Ranibizumab) | -115.14 | 95% Confidence Interval -123.14 to -107.14 | um | |
| Percentage of Subjects With Loss of <15 BCVA Letters | Xlucane (Proposed Ranibizumab Biosimilar) | Missing at random (MAR) | 94.8 | percentage of responders | |
| Percentage of Subjects With Loss of <15 BCVA Letters | Lucentis (Ranibizumab) | Missing at random (MAR) | 96.0 | percentage of responders |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xlucane (Proposed Ranibizumab Biosimilar) | 292 | |
| Overall Study | STARTED | Lucentis (Ranibizumab) | 290 | |
| Overall Study | COMPLETED | Xlucane (Proposed Ranibizumab Biosimilar) | 245 | |
| Overall Study | COMPLETED | Lucentis (Ranibizumab) | 241 | |
| Overall Study | NOT COMPLETED | Xlucane (Proposed Ranibizumab Biosimilar) | 47 | |
| Overall Study | NOT COMPLETED | Lucentis (Ranibizumab) | 49 |
Source ClinicalTrials.gov
Adverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival Haemorrhage | Eye disorders | Xlucane (Proposed Ranibizumab Biosimilar) | 15 | 292 | 19 |
| other | Conjunctival Haemorrhage | Eye disorders | Lucentis (Ranibizumab) | 16 | 290 | 22 |
| other | Hypertension | Vascular disorders | Xlucane (Proposed Ranibizumab Biosimilar) | 10 | 292 | 10 |
| other | Hypertension | Vascular disorders | Lucentis (Ranibizumab) | 17 | 290 | 19 |
| serious | Retinal pigment epithelial tear | Eye disorders | Xlucane (Proposed Ranibizumab Biosimilar) | 2 | 292 | 2 |
| serious | Retinal pigment epithelial tear | Eye disorders | Lucentis (Ranibizumab) | 1 | 290 | 2 |
| serious | Retinal Haemorrhage | Eye disorders | Xlucane (Proposed Ranibizumab Biosimilar) | 1 | 292 | 1 |
| serious | Retinal Haemorrhage | Eye disorders | Lucentis (Ranibizumab) | 1 | 290 | 1 |
| serious | Macular vasospasm | Eye disorders | Xlucane (Proposed Ranibizumab Biosimilar) | 1 | 292 | 1 |
| serious | Macular vasospasm | Eye disorders | Lucentis (Ranibizumab) | 0 | 290 | 0 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xlucane (Proposed Ranibizumab Biosimilar) | 8 | 292 |
| Total, all-cause mortality | Lucentis (Ranibizumab) | 3 | 290 |
| Total, other adverse events | Xlucane (Proposed Ranibizumab Biosimilar) | 25 | 292 |
| Total, other adverse events | Lucentis (Ranibizumab) | 33 | 290 |
| Total, serious adverse events | Xlucane (Proposed Ranibizumab Biosimilar) | 33 | 292 |
| Total, serious adverse events | Lucentis (Ranibizumab) | 35 | 290 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Xlucane (Proposed Ranibizumab Biosimilar) vs Lucentis (Ranibizumab): deaths from any cause | Trial comparisons |
| Xlucane (Proposed Ranibizumab Biosimilar) vs Lucentis (Ranibizumab): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03805100
GET https://conductscience.org/api/trials/v1/NCT03805100/results?page=2