Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PDS with Ranibizumab/mL · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| PDS Implant Cohort 1 (US only) | EXPERIMENTAL | Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 2 (US only) | EXPERIMENTAL | Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 3 (US only) | EXPERIMENTAL | Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 4 (US only) | EXPERIMENTAL | Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 5 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| PDS Implant Cohort 6 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| PDS Implant Cohort 7 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| Sub-study 1: PDS Implant | EXPERIMENTAL | Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W. |
| Sub-study 2: Cohort 1 | EXPERIMENTAL | Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W. |
| Sub-study 2: Cohort 2a | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. |
| Sub-study 2: Cohort 2b | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. |
| Name | Type | Description |
|---|---|---|
| PDS Implant with Ranibizumab 100 mg/mL | DRUG | Will be administered as per the schedule described in individual arm |
Inclusion Criteria: * Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24...
PDS with Ranibizumab/mL is used for neovascular age-related macular degeneration (nAMD), a chronic eye condition that causes vision loss. It is an investigational therapy being developed as a Port Delivery System that releases ranibizumab over time to treat the disease.
PDS with Ranibizumab/mL is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate this treatment for neovascular age-related macular degeneration.
PDS with Ranibizumab/mL is in Phase 3 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The Phase 3 trial is currently recruiting participants to further evaluate its safety and efficacy.
PDS with Ranibizumab/mL is being studied in a Phase 3 trial with the identifier NCT03683251, titled "Extension Study for the Port Delivery System With Ranibizumab (Portal)." This trial is recruiting 1,000 participants with neovascular age-related macular degeneration across multiple countries.
Yes, PDS with Ranibizumab/mL is also known as PDS Implant with Ranibizumab 100 mg/mL. Both names refer to the same investigational Port Delivery System implant that delivers ranibizumab for the treatment of neovascular age-related macular degeneration.
PDS with Ranibizumab/mL is a Port Delivery System implant that continuously releases ranibizumab, a medication that targets vascular endothelial growth factor (VEGF) to reduce abnormal blood vessel growth and leakage in the eye. This mechanism aims to manage neovascular age-related macular degeneration.