Intravitreal Faricimab in Patients With Refractory Macular Edema

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: Faricimab Injection

• Registration Number: NCT07093385
• Lead Sponsor: Baghdad college of medicine

Brief 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.

Study Timeline

• Study Start: 2024-09-10
• Primary Completion: 2025-06-01
• Status Verified: 2025-07
• Study Completion: 2025-07-01
• Study First Submitted: 2025-07-12
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 1. Aged 45 years or older 2. DME, RVO edema, or wet-AMD diagnosed by clinical evidence and optical coherence tomography angiography (OCTA).

  2. Previously treated with:

  • At least six doses of Avastin in DME or RVO edema cases or 3 dose of Avastin in AMD cases in the last year.

  • At least five doses of Eylea in DME or RVO edema cases or 3 dose of Eylea in AMD cases in the last year.

    4. Lack of significant anatomical or visual improvement (i.e., primary non-responders) 5. Willingness and ability to attend follow-up appointments and comply with treatment protocol.

Exclusion Criteria

• 1. Inconsistent treatment history: missed a dose of anti-VEGF doses, or incomplete the three loading doses of Faricimab.

  2. Ocular comorbidities that could confound outcomes, such as:

  • Visually significant cataract as Grade 3+ or more.
  • Corneal opacity.
  • uveitis
  • Uncontrolled glaucoma (IOP > 25 mmHg on meds) with an increase in cup/disc ratio.
  • Other macular pathologies (e.g., macular hole, epiretinal membrane ERM) 3. Severe baseline vision loss (BCVA < 6/60).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
faricimab	Faricimab Injection	Eligible participants received monthly intravitreal injections of Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment, following standard aseptic protocols. Patients observation and examination repeated after One month from the last injection to assess treatment response (BCVA, IOP and SD-OCT re-evaluation).The response to Faricimab was determined using both anatomical (CRT) and functional (BCVA) markers

Primary Outcome Measures

Name	Time	Method
central retinal thickness	one month after the last faricimab injection	optical coherence tomography angiography

Trial Locations

Locations (1)

Baghdad university; 🇮🇶 Baghdad, Iraq