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Vamikibart · 4 trials · 2 indications
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study \[ETDRS\] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
BCVA was measured via Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters using a set of three Precision vision\^TM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity (VA) examiner. The BCVA letter score ranges from 0 to 100 letters. Higher scores and gain in BCVA from baseline indicate improvement in VA. This analysis used a Mixed Model for Repeated Measurements (MMRM) model.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. |
| Arm B | EXPERIMENTAL | Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. |
| Arm C | SHAM_COMPARATOR | Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. |
| Arm A: 0.25 mg Vamikibart Q8W | EXPERIMENTAL | Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. |
| Arm B: 1.0 mg Vamikibart Q8W | EXPERIMENTAL | Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. |
| Arm C: 1.0 mg Vamikibart Q4W | EXPERIMENTAL | Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections. |
| Arm D: 0.5 mg Ranibizumab Q4W | ACTIVE_COMPARATOR | Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections. |
| Arm A: Vamikibart + Ranibizumab | EXPERIMENTAL | Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72. |
| Arm B: Ranibizumab | ACTIVE_COMPARATOR | Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72. |
| Name | Type | Description |
|---|---|---|
| Vamikibart | DRUG | Participants will receive vamikibart IVT injection |
| Sham | OTHER | Participants will receive a sham procedure that mimics an IVT injection. |
| Ranibizumab | DRUG | Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm. |
| Sham Procedure | OTHER | Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms. |
Inclusion Criteria: * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol * Diagnosis of macular edema associated with non-infectious uveitis (NIU) * Diagnosis of active or inactive, acute, or chronic NIU of any ...
Vamikibart is an investigational small molecule being developed for diabetic macular edema and uveitic macular edema, both of which are eye conditions that cause vision loss. It is currently in clinical development and has not been approved by regulatory authorities.
Vamikibart is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The drug is also known by the code name RO7200220 in clinical trial records.
Vamikibart has completed Phase 2 and Phase 3 clinical trials. Two Phase 2 trials in diabetic macular edema and two Phase 3 trials in uveitic macular edema have all been completed. The drug remains investigational and has not received regulatory approval.
Vamikibart has been studied in four completed trials. NCT05151731 and NCT05151744 were Phase 2 studies in diabetic macular edema, with 394 and 187 participants respectively. NCT05642312 and NCT05642325 were Phase 3 studies in uveitic macular edema, enrolling 245 and 256 participants.
Yes, Vamikibart is also known as RO7200220. Clinical trial records for the drug list both names, with RO7200220 appearing as the code name in study titles. Researchers and investors may encounter either name when reviewing the drug's clinical development history.
Vamikibart is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on macular edema, a condition characterized by fluid accumulation in the retina.