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PDS filled with/mL Ranibizumab · 1 trial · 1 indication
The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study. The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
| Arm | Type | Description |
|---|---|---|
| PDS Implant Arm | EXPERIMENTAL | Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals |
| Intravitreal Arm | ACTIVE_COMPARATOR | Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
| Name | Type | Description |
|---|---|---|
| PDS Implant filled with 100 mg/mL Ranibizumab | DRUG | Will be administered as per the schedule described in individual arm. |
| Intravitreal Injections of 10 mg/mL Ranibizumab | DRUG | Will be administered as per the schedule described in individual arm. |
Inclusion Criteria: * Age ≥50 years, at time of signing Informed Consent Form * Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit * Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF...
PDS filled with/mL Ranibizumab is an investigational ophthalmology treatment being studied for neovascular age-related macular degeneration, also known as wet AMD. It combines the Port Delivery System, a sustained-release implant, with the monoclonal antibody ranibizumab. It is in Phase 3 clinical development and is being developed by Roche Holding AG.
PDS filled with/mL Ranibizumab is being studied for the treatment of neovascular age-related macular degeneration, the wet form of AMD. This condition involves abnormal blood vessel growth under the retina. The Phase 3 trial enrolled participants aged 50 years and older with wet AMD in the United States.
PDS filled with/mL Ranibizumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the Phase 3 clinical program evaluating the Port Delivery System filled with ranibizumab in patients with neovascular age-related macular degeneration.
PDS filled with/mL Ranibizumab is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and no trials are currently listed as active. The drug is investigational and has not been established as approved for commercial use based on the available development information.
PDS filled with/mL Ranibizumab has been evaluated in the Phase 3 trial NCT03677934, titled a study of the Port Delivery System with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration. The trial was completed, enrolled 415 participants, was randomized, and used an active-controlled design.