Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LUCENTIS is indicated for the treatment of patients with: LUCENTIS, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Myopic Choroidal Neovascularization (mCNV) ( 1.5 )… FDA label
Also known as Intravitreal Ranibizumab, RO4893594, Lucentis
Ranibizumab · 10 trials · 8 indications
BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in visual acuity (VA).
EDTRS = Early Treatment Diabetic Retinopathy Study. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.
Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.
BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Protocol-Defined Refill Criteria At 1 month after initial fill: * Decrease of ≥ 10 letters in BCVA at the current visit compared with the baseline BCVA, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um at the current visit compared with the baseline CFT, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity For subsequent assessments: * Increase in CFT of ≥ 75 μm on SD-OCT at the current visit compared with the average CFT over the last 2 available measurements, due to nAMD disease activity OR * Increase in CFT of ≥ 100 um from the lowest CFT measurement on study, due to nAMD disease activity OR * Decrease of ≥ 5 letters in BCVA at the current visit compared with the average BCVA over the last 2 available measurements, due to nAMD disease activity OR * Decrease of ≥ 10 letters from best recorded BCVA on study, due to nAMD disease activity OR * Presence of new macular hemorrhage, due to nAMD disease activity
| Arm | Type | Description |
|---|---|---|
| Port Delivery System (PDS) | EXPERIMENTAL | Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) \[approximately 2-milligrams (mg) dose\] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W. |
| Implant Arm | EXPERIMENTAL | Participants will have the implant (pre-filled intraoperatively with ranibizumab 100 mg/mL) surgically inserted on Day 1. After Day 1, participants in the implant arm will attend monthly study visits, and receive implant refill-exchanges with ranibizumab 100 mg/mL at Week 24 and Week 48. At the Week 48 study visit, participants will move to the long -term extension phase of the study and continue receiving refill-exchanges Q24W until the end of study. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion. |
| IVT Arm | EXPERIMENTAL | Participants will receive IVT ranibizumab 0.5 mg injections starting on Day 1. Participants will receive IVT ranibizumab 0.5 mg Q4W until Week 44. At the Week 48 study visit, participants will receive the PDS implant (pre-filled intraoperatively with ranibizumab 100 mg/mL), move to the long-term extension phase of the study and receive Q24W refill exchanges until the end of study. If participants are unable to attend the Week 48 visit due to extenuating circumstances, they should return no later than the next scheduled visit (Week 52), when they will receive the PDS implant. Participants will attend monthly visits up to Week 96 and bi-monthly visits thereafter, followed by visits every two months until study completion. |
| Arm A [Q36W] 36-weeks between refill-exchange procedures | EXPERIMENTAL | Participants randomized to the Q36W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q36W fixed interval. |
| Arm B [Q24W] 24-weeks between refill-exchange procedures | ACTIVE_COMPARATOR | Participants randomized to the Q24W arm will receive PDS implant refill-exchange procedures (ranibizumab 100 mg/mL) on a Q24W fixed interval. |
| Ranibizumab PFS | EXPERIMENTAL | Healthcare professionals (HCPs) will administer ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1. |
| Ranibizumab 0.5 mg monthly | EXPERIMENTAL | Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. |
| Ranibizumab 2.0 mg monthly | EXPERIMENTAL | Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months. |
| Ranibizumab 0.5 mg as-needed (pro re nata [PRN]) | EXPERIMENTAL | Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. |
| Ranibizumab 2.0 mg as-needed (pro re nata [PRN]) | EXPERIMENTAL | Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally. |
| Sham injection | SHAM_COMPARATOR | - |
| Ranibizumab injection 0.3 mg | EXPERIMENTAL | - |
| Ranibizumab injection 0.5 mg | EXPERIMENTAL | - |
| Ranibizumab 0.3 mg | EXPERIMENTAL | Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. |
| Ranibizumab 0.5 mg | EXPERIMENTAL | Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. |
| Sham injection/ranibizumab 0.5 mg | SHAM_COMPARATOR | Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. |
| Port Delivery System with Ranibizumab 10mg/mL | EXPERIMENTAL | Participants had the Implant (prefilled with approximately 20 μL of 10-mg/mL ,approximately 0.2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 10-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| Port Delivery System with Ranibizumab 40mg/mL | EXPERIMENTAL | Participants had the Implant (prefilled with approximately 20 μL of 40-mg/mL, approximately 0.8 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 40-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| Port Delivery System with Ranibizumab 100mg/mL | EXPERIMENTAL | Participants had the Implant (prefilled with approximately 20 μL of 100-mg/mL, approximately 2 mg dose, of ranibizumab) surgically inserted in the study eye at the Day 1 visit following their randomization visit. Starting at the Month 1 visit, participants were evaluated monthly for the need for Implant refill with the 100-mg/mL formulation of ranibizumab according to their randomization as per protocol-specified refill criteria. |
| Intravitreal Injection with Ranibizumab 0.5mg | ACTIVE_COMPARATOR | Participants received ranibizumab 0.5 mg monthly ITV injections of 10 mg/mL formulation at Day 1 and every month thereafter. |
| Name | Type | Description |
|---|---|---|
| Susvimo PDS Implant | DEVICE | Ranizumab will be administered via a PDS implant per the schedule described in the arm. |
| Ranibizumab | DRUG | Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment. |
| PDS With Ranibizumab (100 mg/mL) | DEVICE | Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100 mg/mL formulation of ranibizumab \[approximately 2 mg dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals. |
| Ranibizumab (10 mg/mL) | DRUG | Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg/mL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterwards, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44 and bi-monthly visits thereafter, followed by visits every two months until study completion. |
| Port Delivery System with Ranibizumab | DEVICE | Arm A: 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 36-week intervals Arm B: 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 |
| Sham injection | DRUG | Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections. |
| Ranibizumab injection 0.3 mg | DRUG | Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. |
| Ranibizumab injection 0.5 mg | DRUG | Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections. |
Inclusion Criteria: * Initial diagnosis of nAMD within 24 months prior to screening * Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening * Demonstrated response to prior anti-VEGF IVT trea...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Ranibizumab is used to treat ophthalmology conditions including neovascular age-related macular degeneration, macular edema, and macular edema secondary to retinal vein occlusion. It is also studied in diabetes mellitus related eye disease. It is given as an intravitreal injection or delivered through a port delivery system into the eye.
Ranibizumab targets VEGFA, vascular endothelial growth factor A. It is a monoclonal antibody that acts as an inhibitor of VEGFA, binding the target to block its activity. By inhibiting VEGFA, ranibizumab is designed to reduce the abnormal vessel growth and leakage associated with neovascular age-related macular degeneration and macular edema.
Ranibizumab is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical development program for ranibizumab, including the Phase 3 studies of the port delivery system in neovascular age-related macular degeneration.
Ranibizumab is in Phase 3 clinical development. It is an investigational therapy in the studies tracked here, and the program includes randomized, double-blind, controlled trials. The Phase 3 trials cover neovascular age-related macular degeneration and macular edema, with a combined enrollment of about 1,097 participants.
Ranibizumab is being studied in Phase 3 trials including NCT06847542, a recruiting study of 36-week refill exchanges of the port delivery system in nAMD, and NCT05562947 in Chinese participants with nAMD. NCT04657289, the Velodrome study, evaluates a 36-week refill regimen in nAMD, and NCT02698566 assessed prefilled syringe usability.
Yes. Ranibizumab is also known as ranibizumab 10 mg/mL, intravitreal ranibizumab, intravitreal ranibizumab 0.5 mg injection, ranibizumab injection 0.3 mg, and Lucentis. These names refer to the same monoclonal antibody and its prefilled syringe presentations used for intravitreal administration.