Trials / Unknown
UnknownNCT02810808
Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD
Random, Open-label Multicenter, Phase IV Study Assessing the Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Detailed description
Inclusion Criteria： Age ≥ 50 y/o, nAMD patients（including PCV） Best-corrected visual acuity（BCVA） Exclusion Criteria： Previous anti-VEGF treatment within 3 months History of intraocular surgery within 3 months or arrangement of intraocular surgery in the next 6 months from baseline Active or recent intraocular inflammation in the study eye Primary Endpoint： Improvement in BCVA compared to baseline Other： Central Macular Thickness after Treatment，Numbers of Injections
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 1+PRN | PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month. |
| PROCEDURE | 3+PRN | PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does. |
| DRUG | Ranibizumab | Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-09-01
- Completion
- 2017-01-01
- First posted
- 2016-06-23
- Last updated
- 2016-11-04
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02810808. Inclusion in this directory is not an endorsement.