Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...