Phase 2
N=12
Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-related Macular Degeneration (AMD)
Bottom Line
View on ClinicalTrials.gov: NCT00284089 ↗Enrolled (actual)
12
Serious AEs
16.5%
Results posted
Feb 2011
Primary outcome: Primary: Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B — 47.6; 48.1; 55.7; 57.1 Number of Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 6 in Group B |
47.6; 48.1; 55.7; 57.1; 8.1; 9.0 | — |
| SECONDARY Mean Change From Baseline in the Best Corrected Visual Acuity Score of the Study Eye at Month 12 in Group B |
47.6; 48.1; 57.1; 58.6; 9.5; 10.5 | — |
| SECONDARY Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Month 6 and Month 12 in Group B |
34; 41; 34; 41; 12; 10 | — |
| SECONDARY Extension Phase: Mean Change From Month 12 (Start of Extension Phase) in Best Corrected Visual Acuity Score of the Study Eye at Last Visit of Extension Phase in Group B. |
47.9; 50.0; 59.1; 59.8; 55.4; 57.6 | — |
| SECONDARY Extension Phase: Categorical Analysis of Best Corrected Visual Acuity of the Study Eye at Last Visit of Extension Phase in Group B |
24; 32; 9; 9; 1; 1 | — |
| SECONDARY Mean Change From Baseline in Total Area of Choroidal Neovascularization of the Study Eye in Group B |
2.11; 2.03; -0.10; 0.13; -0.15; 0.04 | — |
| SECONDARY Mean Change From Baseline in Total Area of Leakage From CNV Plus Staining of Retinal Pigment Epithelium of the Study Eye in Group B |
2.31; 2.49; -0.76; -0.74; -1.21; -1.10 | — |
| SECONDARY Percentage of Participants in Group B With Absence of Leakage in the Study Eye at Month 3, 6, 9 and 12. |
2.9; 7.5; 8.8; 15.0; 26.5; 25.0 | — |
| SECONDARY Mean Change From Baseline in Foveal Retinal Thickness of the Study Eye in Group B |
336.7; 370.7; -124.4; -195.6; -142.9; -225.6 | — |
| SECONDARY Mean Change From Baseline in Total Retinal Volume of the Study Eye in Group B |
7.23; 7.36; -0.78; -0.67; -0.52; -0.92 | — |
Summary
Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD).
Eligibility Criteria
Inclusion Criteria
- Male or female patients 50 years of age or greater
- Patients with primary or recurrent subfoveal CNV secondary to AMD
- Patients who have a BCVA score between 73 and 24 letters in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Exclusion Criteria
- No prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
Extension Phase
Inclusion criteria
- Personally provided written informed consent to participate in the extension phase.
- Patients with subfoveal CNV secondary to AMD who had completed the multiple dose phase in either of the ranibizumab groups (Group A or B).
- Patients could participate in the extension phase even if they failed to do so on the day of the exit visit in the multiple dose phase (Group A and B), regardless of the time elapsed until the participation in the extension phase.
Exclusion criteria
- Received anti-angiogenic drugs (bevacizumab, pegaptanib, ranibizumab, anecortave acetate, corticosteroids or protein kinase C inhibitors, etc.) or
- Participated in any clinical study of an investigational drug other than this one during the period between the exit visit of the multiple dose phase and the start in the extension phase, if they failed to be enrolled into the extension on the day of the exit visit. Patients were to be excluded even when the fellow eye was treated with any of these drugs.
Data sourced from ClinicalTrials.gov (NCT00284089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.