Prospective comparative trial of efficacy of faricimab 6.0 mg vs aflibercept 2.0 mg in neovascular age related macular degeneration in indian population
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to compare faricimab and aflibercept to treat neovascular age related macular degeneration using differences in mean best visual acuity after six months in two groups
研究概览
简要总结
Neovascular Age-related macular degeneration (AMD) encompasses progressive retinal degenerative changes affecting the macula and hence affecting central vision. It affects mainly the aged population. None of the currently available treatments cures or reverses the disease. Introduction of Anti- VEGF for its treatment has led to therapeutic advancement in managing nAMD.
Introduction of Faricimab offers a possible hope of achieving of q12weeks - q16 weeks goals in almost half of the population as evidenced in the STAIRWAY phase 2 and phase 3. However, these trials were conducted on patients outside India. Faricimab is a bispecific antibody which targets both Ang-2 and vascular endothelial growth factor-A (VEGF-A) hence sustained efficacy for longer treatment intervals for age related macular degeneration.
Our study encompasses intravitreal injection either Faricimab 6.0 mg or Aflibercept 2.0 mg intravitreal in the affected eye under topical anaesthesia under asepsis after taking informed consent. Patients will be examined at 0, 4 & 8 weeks and all patients will receive 3 four-weekly loading dose. Following this all patients would be examined at 4 weekly intervals for disease activity assessment.
Disease activity will be monitored and at the end we shall be comparing the results of the two arms of the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •BCVA LESS THAN 6/6 IN AFFECTED EYE NEOVASCULAR AMD ON OCT MACULA SRF/IRF.
排除标准
- •History of any form of uvietis History of systemic vasculitis Coexisting ocular or retinal morbidity other than nAMD Any form of central cataract in phakic patients Any posterior capsular opacification or IOL subluxation in pseudophakic patients Pregnancy Systemic contraindications to anti vegf therapy.
结局指标
主要结局
to compare faricimab and aflibercept to treat neovascular age related macular degeneration using differences in mean best visual acuity after six months in two groups
时间窗: baseline and at the end of 4 weeks then 8 weeks then 12 weeks till 78 weeks
次要结局
- to determine the number of patients maintaining q12 weeks dosing interval of faricimab at the end of 78 weeks.(to determine the risk of adverse drug reactions with faricimab whenn compared with aflibercept)
研究者
Sqn Ldr Shailaza Tripathi
Army Hospital Research and Referral Delhi