Skip to content

An observational study of Faricimab in the treatment of neovascular age-related macular degeneration with refractory pigment epithelium detachment

An observational study of Faricimab in the treatment of neovascular age-related macular degeneration with refractory pigment epithelium detachment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082177
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wet age-related macular degeneration

Interventions

Intervention group:Accepting one intravitreal injection of 0.05ml Faricimab
Follow up is conducted once a month, and the researcher decides to evaluate based on the standard of repeated administration. At each subsequent follow-up point, the researcher evaluates whether to co

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) nAMD patients with age = 50 years old and mainly serous components (OCT showed low reflex area = 50%) PED 2) The maximum height of PED of the patient's target eye = 300 µm 3) The course of nAMD was more than 6 months, and the patients had received at least 3 other anti-VEGF treatments (abacetin, conbercept, ranibizumab); Or patients who received other anti-VEGF treatment for 3 consecutive months within 6 months, and were willing to receive faresizumab treatment later; 4) At present, the maximum height of PED in retinal pigment epithelium detachment was less than 50 µ m lower than that before three needle anti VEGF treatment;

Exclusion criteria

Exclusion criteria: 1) Patients who voluntarily withdraw; 2) Study eye patients who received laser photocoagulation, PDT, TTT within 3 months before the first treatment with faresizumab 3) Patients with previous vitrectomy in the study eye 4) RPE tear, subretinal fibrosis or atrophy in the study eye at baseline 5) If the target eye is complicated with other eye diseases (such as RVO, Rao, Dr, DME, CSC, etc.), pathological myopia, cataract and other factors affecting refractive media such as vision and fundus observation are excluded 6) Active eye inflammation or suspected/active eye infection in any eye of the patient 7) Patients with systemic drug combination (such as hormone, anti VEGF drugs) or other drugs with potential retinal toxicity 8) Participated in the intervention eye/systemic clinical trial within 28 days before enrollment 9) Patients who cannot provide clinical data within 14 days before dressing change (including but not limited to visual acuity and OCT images) 10) Target eye or systemic presence the researchers believe that if they continue to participate in this study, the patients may face diseases or conditions with greater risk (such as vitrectomy history, grade 3 hypertension, AIDS, malignant tumors, serious mental, cardiovascular, neurological, respiratory, digestive and other system diseases, or long-term use of hormones, immune deficiency diseases, after cardiac stenting, after organ transplantation, etc.); Poor glycemic control in diabetic patients 11) Cardiovascular events such as stroke, cerebral ischemia and myocardial infarction occurred within 6 months before screening; 12) Those who do not use effective contraceptive measures; 13) During the study, the researcher decided that it was not appropriate to continue to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
The change in height of pigment epithelial detachment from baseline at 6 months;

Secondary

MeasureTime frame
The change in height of pigment epithelial detachment from baseline at 12 months;

Countries

China

Contacts

Public ContactYu Suqin

Shanghai General Hospital

sq-yu@163.com+86 137 0173 9566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026