Drugs / Ranibizumab
Ranibizumab
DrugRanibizumab is marketed as Lucentis for intravitreal injection and is used for retinal vascular diseases. Labeling describes it as a VEGF inhibitor, and indications include neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. U.S. labeling lists initial FDA approval in 2006.
- Trials
- 514
- Recruiting
- 8
- Completed
- 352
- With results
- 179
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | — | 3 | — | — | 1 | 4 |
| Phase 1 | — | — | — | — | 39 | 1 | 6 | 2 | 48 |
| Phase 1/2 | — | — | — | — | 37 | 2 | 2 | 5 | 46 |
| Phase 2 | — | — | 1 | 1 | 77 | 12 | 6 | 8 | 105 |
| Phase 2/3 | — | — | — | 3 | 7 | 3 | 1 | 8 | 22 |
| Phase 3 | 5 | 2 | — | 5 | 81 | 7 | 3 | 16 | 119 |
| Phase 4 | 1 | — | — | — | 61 | 6 | 6 | 22 | 96 |
| Not applicable | 1 | — | — | — | 21 | 3 | 2 | 12 | 39 |
| Unknown | 1 | — | — | 1 | 26 | 1 | — | 6 | 35 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Macular Degeneration | 1 | 5 | 14 | 44 | 7 | 49 | 28 | 14 | 14 | 176 |
| Macular Edema | — | 4 | 5 | 15 | 2 | 25 | 16 | 6 | 4 | 77 |
| Retinal Vein Occlusion | — | 5 | 5 | 8 | 1 | 17 | 11 | 6 | 6 | 59 |
| Choroidal Neovascularization | — | 6 | 4 | 14 | 3 | 16 | 10 | 2 | 1 | 56 |
| Diabetic Retinopathy | 1 | 1 | 3 | 10 | — | 9 | 9 | 2 | 2 | 37 |
| Vision Disorders | — | — | — | 5 | — | 15 | 4 | 1 | — | 25 |
| Wet Macular Degeneration | 1 | — | 3 | 5 | 3 | 4 | 6 | 2 | 1 | 25 |
| Retinal Diseases | — | 4 | 3 | 2 | 3 | 5 | 4 | 1 | — | 22 |
| Diabetes Mellitus | — | — | 2 | 5 | 2 | 6 | 3 | 1 | — | 19 |
| Polypoidal Choroidal Vasculopathy | — | 1 | 5 | 1 | 1 | — | 4 | 1 | 1 | 14 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Novartis Pharmaceuticals | 48 | 23 |
| 2 | Genentech, Inc. | 17 | 11 |
| 3 | Hoffmann-La Roche | 17 | 9 |
| 4 | Allergan | 13 | 2 |
| 5 | Novartis | 13 | 7 |
| 6 | National Eye Institute (NEI) | 7 | 0 |
| 7 | Alcon Research | 6 | 0 |
| 8 | California Retina Consultants | 6 | 0 |
| 9 | Johns Hopkins University | 6 | 0 |
| 10 | Ophthotech Corporation | 6 | 2 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Ranibizumab | 514 |
| 2 | Bevacizumab | 49 |
| 3 | aflibercept | 45 |
| 4 | salicylhydroxamic acid | 34 |
| 5 | Dexamethasone | 23 |
| 6 | Verteporfin | 21 |
| 7 | Calcium Dobesilate | 12 |
| 8 | Triamcinolone Acetonide | 11 |
| 9 | Lasers | 10 |
| 10 | faricimab | 6 |
Evidence
- Results reported
- 50.9%179 of 352 completed
- Published
- 11.1%39 of 352 completed
- Primary endpoint met
- 48.4%59 of 122 analyses
- Median months to report
- 16
Documents disclosed
Trial profile
- Median enrollment
- 56
- Median duration
- 30.6months
- Countries
- 67
- Study sites
- 4850
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 14
- Phase 1
- 10
- Phase 1/2
- 26
- Phase 2
- 60
- Phase 2/3
- 90
- Phase 3
- 312
- Phase 4
- 45
- Not applicable
- 40
- Unknown
- 60
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Austin | United States | 53 |
| 2 | Houston | United States | 49 |
| 3 | Phoenix | United States | 49 |
| 4 | Beverly Hills | United States | 48 |
| 5 | Baltimore | United States | 47 |
| 6 | Augusta | United States | 44 |
| 7 | San Antonio | United States | 44 |
| 8 | Fort Myers | United States | 41 |
| 9 | Sacramento | United States | 41 |
| 10 | Salt Lake City | United States | 40 |
Terminations
- Terminated
- 35
- Withdrawn
- 26
- Stopped for recruitment
- 2.3%12 of 514 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT05126966 Withdrawn | Withdrawn | Roche/Genentech has initiated an immediate pause of all new PDS implantations because the implants from commercial supply in the clinical studies did not meet the filed specifications for the intended use | 2026-01-30 |
| NCT04757610 Terminated | Terminated | The primary endpoint was not achieved in the study. | 2025-03-31 |
| NCT04075136 Withdrawn | Withdrawn | IRB stopped study due to safety concerns before any participants were enrolled. | 2024-12-31 |
| NCT03784443 Withdrawn | Withdrawn | Funder withdrawn funding. | 2023-09-01 |
| NCT02207712 Terminated | Terminated | Major protocol deviations compromised the study. | 2023-08-31 |
| NCT04698850 Withdrawn | Withdrawn | funding issues | 2023-06-30 |
| NCT04991350 Terminated | Terminated | Insufficient recruitment | 2022-11-01 |
| NCT03203447 Terminated | Terminated | The early termination is due to the results obtained from the sister study, SAPPHIRE (CLS1003-301), which did not meet the 8-week primary efficacy endpoint. | 2018-12-18 |
| NCT02769169 Terminated | Terminated | study protocol changed | 2018-12-15 |
| NCT02665689 Terminated | Terminated | Enrollment pace was far below target. | 2018-09-07 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: