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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 with ranibizumab, also called the Port Delivery System with ranibizumab, is used for neovascular age-related macular degeneration, also known as wet age-related macular degeneration. It is an investigational treatment designed to deliver ranibizumab continuously through an implant, and it is being studied as an alternative to monthly eye injections.
PDS with ranibizumab is developed by Roche Holding AG, which trades under the ticker RHHBY. The Port Delivery System is an implant that releases ranibizumab over time, and the company is evaluating it in clinical trials for the treatment of neovascular age-related macular degeneration.
PDS with ranibizumab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial, NCT03677934, has been completed, and the treatment is being studied for neovascular age-related macular degeneration.
PDS with ranibizumab has one completed Phase 3 trial, NCT03677934, which enrolled 415 participants with neovascular age-related macular degeneration. The study compared the Port Delivery System with ranibizumab against monthly ranibizumab injections, and it was conducted in the United States.
PDS with ranibizumab is not the same as standard ranibizumab injections. It is a Port Delivery System, an implant that releases ranibizumab continuously over time, whereas ranibizumab injections are given monthly. The Phase 3 trial compared the implant to monthly injections to evaluate its effectiveness.