A Phase 2 interventional study of Faricimab Injection in Age-Related Macular Degeneration, sponsored by University of Baghdad. Completed at 1 site in Iraq. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by University of Baghdad · Phase 2, Interventional, and Treatment
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 43 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 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:
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
Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment,
central retinal thickness
optical coherence tomography angiography
Time frame: one month after the last faricimab injection
Plan to share: Yes
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University of Baghdad