Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00275821 | Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 353 | — | — | Dec 1, 2005 | Jan 1, 2008 | Mar 16, 2011 | 1 | Switzerland |
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...