Age-Related Macular DegenerationPhase 2NCT07093385
Intravitreal Faricimab in Patients With Refractory Macular Edema
A Phase 2 study testing Faricimab Injection in people with Age-Related Macular Degeneration, run by University of Baghdad at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Faricimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIraq
- Study dates
- 10 Sep 2024to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravitreal Faricimab in Patients With Refractory Macular Edema and Refractory Age Related Macular Degeneration
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.
Read the 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
- Being tested
- Faricimab Injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab InjectionDrug
Faricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment,
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Faricimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
central retinal thickness
optical coherence tomography angiography
Measured: one month after the last faricimab injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start10 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duaa jabbar kadhim, University of Baghdad
- Investigators
- Duaa J Kadhim, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093385
- Sponsor's protocol ID
- Ab2222
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitreal Faricimab in Patients With Refractory Macular Edema and Refractory Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07093385
- Acronym / sponsor ID
- Ab2222
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| faricimab | Experimental | Drug: Faricimab InjectionEligible 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 |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Aged 45 years or older 2. DME, RVO edema, or wet-AMD diagnosed by clinical evidence and optical coherence tomography angiography (OCTA).
- 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.
Key exclusion criteria (7 listed)
- 1. Inconsistent treatment history: missed a dose of anti-VEGF doses, or incomplete the three loading doses of Faricimab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faricimab InjectionFaricimab (6 mg/0.05 mL) for three months (loading dose) in a sterile environment, | Drug | faricimab |
Primary outcome
central retinal thickness
Time frame: one month after the last faricimab injection
optical coherence tomography angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes
Related trials for Age-Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duaa J Kadhim principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Faricimab Injection in people with Age-Related Macular Degeneration, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central retinal thickness (time frame: one month after the last faricimab injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.