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Ranibizumab refill exchange
Ranibizumab is a monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A), reducing abnormal blood vessel growth and vascular permeability in the eye.
Ranibizumab is a monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A (VEGF-A), reducing abnormal blood vessel growth and vascular permeability in the eye. Used for Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Retinal vein occlusion.
At a glance
| Generic name | Ranibizumab refill exchange |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | VEGF-A inhibitor (monoclonal antibody fragment) |
| Target | VEGF-A (Vascular Endothelial Growth Factor A) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Ranibizumab blocks VEGF-A, a key driver of pathological neovascularization and increased vascular permeability in retinal diseases. By neutralizing VEGF-A, it prevents the formation of abnormal blood vessels and reduces fluid leakage, thereby slowing or halting vision loss in conditions characterized by excessive angiogenesis. The 'refill exchange' designation likely refers to a formulation or delivery system innovation rather than a mechanistic change.
Approved indications
- Neovascular (wet) age-related macular degeneration
- Diabetic macular edema
- Retinal vein occlusion
- Diabetic retinopathy
- Myopic choroidal neovascularization
Common side effects
- Conjunctival hemorrhage
- Eye pain
- Floaters
- Intraocular pressure elevation
- Endophthalmitis
- Retinal detachment
Key clinical trials
- A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) (PHASE4)
- A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME (PHASE3)
- A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD (PHASE3)
- Extension Study for the Port Delivery System With Ranibizumab (Portal) (PHASE3)
- A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm (PHASE3)
- A 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) (PHASE3)
- A 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) (PHASE3)
- A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ranibizumab refill exchange CI brief — competitive landscape report
- Ranibizumab refill exchange updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI