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Completed

NCT Number: NCT07093385

Intravitreal Faricimab in Patients With Refractory Macular Edema

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.

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Key information

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baghdad university

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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.
  • 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.
  • 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).

Treatment and study plan

Faricimab Injection

Drug

Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment,

Primary outcomes

  1. central retinal thickness

    Time frame: one month after the last faricimab injection

    optical coherence tomography angiography

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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