Phase 4
Completed N=334
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)
Source: ClinicalTrials.gov NCT01775124 ↗Enrolled (actual)
334
Serious AEs
14.5%
Results posted
Feb 2018
Primary outcomePrimary: Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 — 3.3; 1.7 Letters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 |
3.3; 1.7 | — |
| SECONDARY Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24 |
3.7; 2.2 | — |
| SECONDARY Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24 |
10.1; 8.1; 11.0; 8.9 | — |
| SECONDARY Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time |
4.3; 3.4; 6.8; 6.3; 8.0; 7.2 | — |
| SECONDARY Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24 |
75; 65; 27; 31; 11; 17 | — |
| SECONDARY Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time |
164; 163; 163; 162; 160; 162 | — |
| SECONDARY Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More |
68; 56; 63; 59 | — |
| SECONDARY Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24 |
-112.8; -108.7; -141.1; -130.4; -141.3; -141.2 | — |
| SECONDARY Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24 |
2.9; 3.7; 2.1; 3.3; 1.5; 3.0 | — |
| SECONDARY Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12 |
2.7; 2.0; 1.3 | — |
| SECONDARY Duration of Active Treatment Phase Prior to Month 12 |
10.5; 9.1 | — |
| SECONDARY Duration of Active Treatment Phase up to Month 24 |
18.0; 17.1 | — |
Eligibility Criteria
Key Inclusion criteria
- Patients with visual impairment due to neovascular AMD
- A qualifying vision score at study entry Key Exclusion criteria
- Active infection or inflammation either eye at study entry
- Uncontrolled glaucoma in either eye
- Any disorder in the study eye which may affect vision
- Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
- Previous treatment of the study eye for wet AMD
- Any surgery in the study eye 3 months prior to or planned with 6 month after study entry
Data sourced from ClinicalTrials.gov (NCT01775124). 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. Informational only — not medical advice.