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Ranibizumab- 3 times monthly, then quarterly · 1 trial · 1 indication
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
| Arm | Type | Description |
|---|---|---|
| Ranibizumab 0.3 mg - 3 times monthly, then quarterly | EXPERIMENTAL | - |
| Ranibizumab 0.5 mg - 3 times monthly, then quarterly | EXPERIMENTAL | - |
| Ranibizumab 0.3 mg monthly | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ranibizumab 0.3 mg - 3 times monthly, then quarterly | DRUG | Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. |
| Ranibizumab 0.5 mg - 3 times monthly, then quarterly | DRUG | Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. |
| Ranibizumab 0.3 mg monthly | DRUG | Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. |
Inclusion Criteria: * Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component * Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-li...
| 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 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE2 | Iptacopan, FWY003 |
| 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 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
It is used to treat age related macular degeneration, specifically subfoveal choroidal neovascularization secondary to AMD. This dosing schedule of ranibizumab 0.3 mg given three times monthly and then quarterly was studied in a Phase 3 trial in patients with this eye condition.
Novartis AG, which trades under the ticker NVS, is the developer of this ranibizumab dosing regimen. The company sponsored the clinical trial evaluating the 0.3 mg dose administered three times monthly followed by quarterly dosing in patients with age related macular degeneration.
It is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are ongoing for this specific dosing schedule. The trial enrolled 353 patients and was randomized, double blind, and active controlled.
The regimen was studied in NCT00275821, titled Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration. The Phase 3 trial completed with 353 enrolled patients in Switzerland, aged 50 years and older, and was active controlled.
Yes, ranibizumab 0.3 mg - 3 times monthly, then quarterly is an alternative name for ranibizumab when given on that specific dosing schedule. It refers to the same monoclonal antibody treatment, and the full name describes the 0.3 mg dose given three times monthly followed by quarterly dosing.