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Also known as Vamikibart
RO7200220 · 5 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. |
| Part 1: RO7200220 Monotherapy | EXPERIMENTAL | Participants with DME received multiple ascending doses of RO7200220 (two doses at the assigned dose level), as intravitreal (IVT) injection, every 6 weeks (Q6W) in multiple cohorts. |
| Part 2: Expansion of RO7200220 Monotherapy | EXPERIMENTAL | Participants with DME who were anti-VEGF and corticosteroid IVT treatment-naive received three doses of RO7200220 monotherapy, as IVT injection, every 4 weeks (Q4W) in Part 2 cohorts. |
| Part 3: RO7200220 in Combination with Ranibizumab | EXPERIMENTAL | Participants with DME received RO7200220 as IVT injection followed by ranibizumab, 0.5 milligrams (mg) as IVT injection in Part 3. |
| Part 4: RO7200220 Monotherapy | EXPERIMENTAL | Participants with UME received multiple doses of RO7200220 (three doses at the assigned dose level), as IVT injection, Q4W in multiple cohorts. |
| 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. |
| RO7200220 | DRUG | RO7200220 was administered as IVT injection. |
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 ...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
RO7200220 is an investigational small molecule being developed for diabetic macular edema, a condition that causes vision loss due to fluid buildup in the macula. It is also being studied for uveitic macular edema. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
RO7200220 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials of the drug in the United States for diabetic macular edema and uveitic macular edema.
RO7200220 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, but it remains investigational and has not received FDA approval. The drug is being studied for diabetic macular edema and uveitic macular edema.
RO7200220 has one completed clinical trial, NCT06771271, which investigated the drug as monotherapy and in combination with ranibizumab in participants with diabetic and uveitic macular edema. The study enrolled 85 participants in the United States and was Phase 1.
No, RO7200220 is not the same as ranibizumab. RO7200220 is a small molecule being developed by Roche, while ranibizumab is a separate biologic therapy. In clinical trial NCT06771271, RO7200220 was studied as a monotherapy and in combination with ranibizumab.