A Phase 2 interventional study of SB11 PFS in Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema and Central Retinal Vein Occlusion With Macular Edema, sponsored by Samsung Bioepis Co., Ltd.. Completed at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 2, Interventional, and Treatment
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Among 125 studies testing ranibizumab in Macular Degeneration — 3 open to participants now, 6 under way, 4 of them phase 3. Ranibizumab · Macular Degeneration.
Among the 125 studies testing ranibizumab in Macular Degeneration, this one is the 91st largest by enrollment of the 124 interventional ones that give a count, is the only one that started in 2026, is one of 24 in phase 2, and was the 125th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
Browse Macular Degeneration studies →3 of the 125 studies testing ranibizumab in Macular Degeneration are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Austria, Czechia, Denmark and 10 more countries
Ages 50+
AO GENERIUM · Sites in Russian Federation
Ages 50+
AbbVie · Sites in United States
By country, each count listing its studies:
Ranibizumab: first FDA approval 2006 (LUCENTIS), first EMA approval 2007. What it is approved for, and how studies give it, is on its page →
Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 43 · Phase 3 35 · Phase 4 33
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Median enrollment 64 across the 124 interventional studies. Of the 98 that completed or were terminated, 42 (43%) have results posted.
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58 of 125 have an industry lead sponsor. The 10 most frequent:
Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Samsung Bioepis Co., Ltd. has 4 studies filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
3 of the studies testing ranibizumab in Macular Degeneration that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT05562947Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD) | 2027-06-30 |
| NCT04853251Genentech, Inc.A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) | 2027-07-30 |
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Among the 125 studies testing ranibizumab in Macular Degeneration, from their registry updates:
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This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).
HCPs will prepare and administer intravitreal injections of SB11 0.5 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.
Only one eye will be selected as the study eye.
Key Inclusion Criteria:
Key Exclusion Criteria:
Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.
Combination Product: SB11 PFS
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection
Also known as: ranibizumab
Percentage of Successful Task Completions on All of the 12 tasks
A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured.
Time frame: Day 1
Percentage of Successful Completion on Each of 12 tasks
Time frame: Day 1
Incidence of AEs and serious adverse events (SAEs)
Time frame: From Day 1 to Day 7
Change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: From Day 1 to Day 7
Ran from Mar 2026 to primary completion in Mar 2026, 0 months.
Of 66 industry-sponsored phase 2 interventional studies under Macular Degeneration, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 0 months is below that.
Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 16 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ranibizumab