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Clinical study protocol to observe the effect of intravitreal injection of faricimab on the maturity improvement of neovascular age-related macular degeneration (nAMD) with type I macular neovascularization (MNV) by optical coherence tomography angiography (OCTA)

Clinical study protocol to observe the effect of intravitreal injection of faricimab on the maturity improvement of neovascular age-related macular degeneration (nAMD) with type I macular neovascularization (MNV) by optical coherence tomography angiography (OCTA)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097237
Enrollment
Unknown
Registered
2025-02-14
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Age-related macular degeneration (nAMD) with type I macular neovascularization (MNV)

Interventions

Observation group:NA

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: (1)Signed informed consent; (2)Age>= 50 years at the time of informed consent (or at the time of the first dose of faricimab, whichever occurs first) ; (3)Chinese female and male patients, who have been diagnosed with nAMD with immature or mature type I MNV (serous or multilayered pigment epithelial detachment associated with NV tissue in the sub-RPE on OCT, and identified as type I MNV on OCTA) ; (4)Already received at least one dose of faricimab; (5)Never received any anti-VEGF therapy before the first dose of faricimab; (6)Patients were able to cooperate with the treatment process and the 12-month follow-up period.

Exclusion criteria

Exclusion criteria: (1)Active ocular inflammation or suspected/active ocular infection in either eye. (2)Presence of any RPE tear, subretinal fibrosis, or atrophy in the study eye. (3)History of vitrectomy in the study eye. (4)Have other retinal vascular disease other than nAMD or ocular disease affecting visual acuity and fundus observation in the study eye. (5)PDT/TTT within the previous 90 days (6)Patients taking systemic concomitant medications (e.g., hormones, anti-VEGF agents) or other potentially retinotoxic agents that may affect the efficacy of faricimab. (7)Patients who are participating in any other interventional clinical study. (8)For patients who had received faricimab prior to enrollment: Patient unable to provide clinical data (visual acuity, OCT, and OCTA images) 2 weeks (14 days) prior to receiving initial faricimab injection; Received any other anti-VEGF therapy in the study eye after the administration of faricimab.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with MNV maturity improved on OCTA;

Secondary

MeasureTime frame
Visual Acuity;Changes in imaging indicators;

Countries

China

Contacts

Public ContactMeixia Zhang

West China Hospital of Sichuan University

zhangmeixia@scu.edu.cn+86 189 8060 2236

Outcome results

None listed

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