Intravitreal Faricimab in Patients With Refractory Macular Edema

NCT07093385 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Ab2222
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• central retinal thickness

  optical coherence tomography angiography

  one month after the last faricimab injection

Study Arms (1)

faricimab

EXPERIMENTAL

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

Drug: Faricimab Injection

Interventions

Faricimab Injection DRUG

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

faricimab

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Baghdad university

Baghdad, Iraq

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

faricimab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Duaa J Kadhim

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: All patients enrolled in this prospective study were a sample of Iraqi patients diagnosed with resistant AMD, DME or RVO edema. These patients diagnosed as primary non-responders to Bevacizumab, Lucentis or Aflibercept.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.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 30, 2025
• Study Start: September 10, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

IR (1)