Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ranibizumab monthly · 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...
Ranibizumab monthly is an investigational small molecule being studied for the treatment of Age Related Macular Degeneration (AMD). It is administered on a monthly dosing schedule. The drug is currently in Phase 3 clinical development for this ophthalmic condition.
Ranibizumab monthly is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with Age Related Macular Degeneration.
Ranibizumab monthly is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated for the treatment of Age Related Macular Degeneration in a completed Phase 3 clinical trial.
Ranibizumab monthly has been studied in one Phase 3 clinical trial with the identifier NCT00275821. This completed trial, titled 'Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)', enrolled 353 participants in Switzerland.
Yes, Ranibizumab monthly has been evaluated in a randomized, double-blind, active-controlled Phase 3 clinical trial. The study enrolled 353 patients aged 50 years and older with Age Related Macular Degeneration. The trial was conducted in Switzerland and has been completed.