Trial · NCT03150589
A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
NCT03150589, Phase 3, Completed, Samsung Bioepis Co., Ltd.; results first posted 2021-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD). Trials, record NCT03150589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03150589
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- NCT number
- NCT03150589
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 705 participants, actual
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Conditions
- Age-Related Macular Degeneration
- Interventions
- SB11 (Proposed ranibizumab biosimilar), Lucentis (ranibizumab)
- First posted
- 2017-05-12
- Last updated
- 2021-05-21
- Results first posted
- 2021-05-21
- Limitations and caveats
Investigator agree to submit any proposed publication/presentation to Sponsor for review at least sixty days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline and Week 8 | The VA was assessed using original series ETDRS charts or 2702 series number charts. |
| Primary | Change From Baseline in Central Subfield Thickness (CST) | Baseline and Week 4 | The average retinal thickness in the central 1-mm area in the ETDRS grid (CST) was evaluated using (Optical Coherence Tomography) OCT |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline and Week 8 | Full Analysis Set | letters | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Central Subfield Thickness (CST) | Baseline and Week 4 | Per-Protocol Set for CST | μm | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | SB11 (Proposed Ranibizumab Biosimilar) | 6.26 | Standard Error 0.51 | letters | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | Lucentis (Ranibizumab) | 7.08 | Standard Error 0.51 | letters | |
| Change From Baseline in Central Subfield Thickness (CST) | SB11 (Proposed Ranibizumab Biosimilar) | -108.40 | Standard Error 4.65 | μm | |
| Change From Baseline in Central Subfield Thickness (CST) | Lucentis (Ranibizumab) | -100.05 | Standard Error 4.64 | μm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SB11 (Proposed Ranibizumab Biosimilar) | 351 | |
| Overall Study | STARTED | Lucentis (Ranibizumab) | 354 | |
| Overall Study | COMPLETED | SB11 (Proposed Ranibizumab Biosimilar) | 307 | |
| Overall Study | COMPLETED | Lucentis (Ranibizumab) | 327 | |
| Overall Study | NOT COMPLETED | SB11 (Proposed Ranibizumab Biosimilar) | 44 | |
| Overall Study | NOT COMPLETED | Lucentis (Ranibizumab) | 27 |
Source ClinicalTrials.gov
Adverse events204
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 | Neovascular age-related macular degeneration | Eye disorders | SB11 (Proposed Ranibizumab Biosimilar) | 26 | 350 | 26 |
| other | Neovascular age-related macular degeneration | Eye disorders | Lucentis (Ranibizumab) | 24 | 354 | 24 |
| other | Visual acuity reduced | Eye disorders | SB11 (Proposed Ranibizumab Biosimilar) | 21 | 350 | 27 |
| other | Visual acuity reduced | Eye disorders | Lucentis (Ranibizumab) | 23 | 354 | 31 |
| other | Conjunctival haemorrhage | Eye disorders | SB11 (Proposed Ranibizumab Biosimilar) | 19 | 350 | 23 |
| other | Conjunctival haemorrhage | Eye disorders | Lucentis (Ranibizumab) | 19 | 354 | 21 |
| other | Nasopharyngitis | Infections and infestations | SB11 (Proposed Ranibizumab Biosimilar) | 39 | 350 | 44 |
| other | Nasopharyngitis | Infections and infestations | Lucentis (Ranibizumab) | 36 | 354 | 41 |
| other | Intraocular pressure increased | Investigations | SB11 (Proposed Ranibizumab Biosimilar) | 24 | 350 | 47 |
| other | Intraocular pressure increased | Investigations | Lucentis (Ranibizumab) | 29 | 354 | 77 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SB11 (Proposed Ranibizumab Biosimilar) | 0 | 350 |
| Total, all-cause mortality | Lucentis (Ranibizumab) | 0 | 354 |
| Total, other adverse events | SB11 (Proposed Ranibizumab Biosimilar) | 111 | 350 |
| Total, other adverse events | Lucentis (Ranibizumab) | 126 | 354 |
| Total, serious adverse events | SB11 (Proposed Ranibizumab Biosimilar) | 52 | 350 |
| Total, serious adverse events | Lucentis (Ranibizumab) | 52 | 354 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| SB11 (Proposed Ranibizumab Biosimilar) vs Lucentis (Ranibizumab): deaths from any cause | Trial comparisons |
| SB11 (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/NCT03150589
GET https://conductscience.org/api/trials/v1/NCT03150589/events?page=2