NCT07093385CompletedPhase 2
Intravitreal Faricimab in Patients With Refractory Macular Edema
The Effect of Intravitreal Faricimab in Patients With Refractory Macular Edema and Refractory Age Related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 30 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 12 Jul 2025
- Start date
- 10 Sept 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- University of Baghdad
- Diseases
- Macular degeneration
- NCT number
- NCT07093385
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 10 Sept 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 45 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baghdad university Coordinator of this site? Confirm its status | Baghdad | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.