Intravitreal Faricimab in Patients With Refractory Macular Edema

NCT ID: NCT07093385

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-07-01

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

faricimab

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

Group Type: EXPERIMENTAL

Faricimab Injection

Intervention Type: DRUG

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

Interventions

Faricimab Injection

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

Intervention Type: DRUG

Eligibility Criteria

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).

3. 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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baghdad college of medicine

OTHER

Sponsor Role: lead

Responsible Party

Duaa jabbar kadhim

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duaa J Kadhim

Role: PRINCIPAL_INVESTIGATOR

Baghdad college of medicine

Locations

Baghdad university

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

Ab2222

Identifier Type: -

Identifier Source: org_study_id