NCT07093385

Intravitreal Faricimab in Patients With Refractory Macular Edema

The Effect of Intravitreal Faricimab in Patients With Refractory Macular Edema and Refractory Age Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema.The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab. All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity and central macular thickness.

Detailed description

This prospective study will include about 40 patients with resistant wet age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion edema (RVO) edema. The inclusion criteria are that all patients must be 40 years old or older, diagnosed with active wet AMD or macular edema due to RVO or DME, and have received at least four previous monthly injections of anti-VEGF other than faricimab. All patients will be switched to receive four loading doses of intravitreal faricimab (6 mg) at 4-week intervals for four months. The response to faricimab will be assessed regarding visual acuity (functionally), central macular thickness, and the presence of subretinal or intraretinal fluid (anatomically) by optical coherence tomography OCT and compared with pre-injection visual acuity and OCT.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Faricimab Injection	Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment,

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: Iraq

Regulatory

• FDA-regulated drug study