A Phase 4 interventional study of Intravitreal faricimab injection in Age-related Macular Degeneration (ARMD), Choroidal Neovascularization and Anti-vascular Endothelial Growth Factor, sponsored by Kim's Eye Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Kim's Eye Hospital · Phase 4, Interventional, and Treatment
Type 3 macular neovascularization (MNV) is a subtype of neovascular age-related macular degeneration accounting for 10-20% of cases, notable for high rates of bilateral involvement and risk of profound vision loss, particularly if undertreated. Early and proactive therapy is crucial to prevent progression and preserve vision.
Faricimab offers potential advantages in this setting. Eyes with type 3 MNV often show thin choroid, reticular pseudodrusen, and high GA risk, reflecting compromised choroidal perfusion. While anti-vascular endothelial growth factor (VEGF) agents suppress neovascularization, prolonged VEGF blockade may impair choriocapillaris health. Ang-2 inhibition, by promoting Tie2 activation and vascular stability, may protect choriocapillaris and reduce widespread retinal edema and hemorrhages observed in type 3 MNV.
Finally, while treat-and-extend is widely used in practice, existing trials (TENAYA, LUCERNE) applied broader extension intervals than typically used clinically. In type 3 MNV, where undertreatment carries severe consequences, a more stringent faricimab-based treat-and-extend regimen with 2-week interval adjustments warrants investigation.
1.1 The Nature of Type 3 macular neovascularization (MNV) and Recommended Therapeutic Approaches Type 3 MNV, also known as retinal angiomatous proliferation is a subtype of neovascular age-related macular degeneration (AMD) that is characterized by intraretinal neovascularization. The incidence of type 3 neovascularization is relatively lower than other subtypes of neovascular AMD, constituting 10 to 20% of entire neovascular AMD. However, it is a very important disorder because it often leads bilateral visual deterioration. The high risk of bilateral involvement is characteristic of type 3 neovascularization. In some cases, the visual prognosis of the initially uninvolved eye with better vision, is poorer than the initially involved eye. In addition, profound visual loss may occur during the treatment course, especially in undertreated cases.
Thus, preserving vision is particularly important in type 3 neovascularization, which subsequently highlights the importance of investigating more effective treatment strategies. We previously suggested the need for proactive treatment in type 3 neovascularization to reduce the risk of abrupt visual loss. Furthermore, due to the progressive nature of type 3 MNV, there is an increased risk of visual impairment as the stages advance. Therefore, it is imperative to administer aggressive treatment during the early phase of the disorder to impede the progression of disease stages.
1.2 Why is Faricimab Particularly Advantageous for Type 3 MNV? (My own hypothesis) 1.2.1 The potential of ang-2 inhibition in preserving choriocapillaris Eyes with type 3 MNV usually exhibits very thin choroid, a high prevalence of reticular pseudodrusen, and a lack of choroidal vascular hyperpermeability. These observations collectively indicate compromised choroidal perfusion in such eyes. In fact, the occurrence of geographic atrophy (GA) is particularly elevated in type 3 MNV, and it serves as a significant contributing factor to the progressive deterioration of visual acuity over the long term in this condition. Due to these factors, maintaining adequate choroidal perfusion becomes particularly crucial in the treatment of type 3 MNV.
The choriocapillaris is the most critical tissue for perfusion into the retinal pigment epithelium and retinal outer layers. While anti-vascular endothelial growth factor (VEGF) therapy is highly effective in stabilizing neovascularization, there have been concerns regarding its potential negative impact on the maintenance of retinal pigment epithelium and choriocapillaris by suppressing physiological VEGF, particularly following aflibercept therapy. In 2016, I was the first to propose the possibility that these aspects could pose a concern in the management of patients with type 3 MNV during actual clinical practice.
It has been demonstrated in animal models of choroidal neovascularization that tie2 activation has the potential to induce choriocapillaris regeneration. It is not yet certain whether such phenomena occur in humans. Nonetheless, these research findings can provide support for the hypothesis that tie2 activation through ang-2 inhibition could potentially confer benefits in cases of compromised choroidal perfusion, such as in type 3 MNV.
1.2.2 The importance of promoting vascular stability in the treatment of type 3 MNV In Type 3 MNV, it is well-known that the neovascular lesion itself is often accompanied by extensive and severe retinal edema disproportionate to its size. Additionally, retinal hemorrhages unrelated to the location of the neovascular lesion can frequently occur. Dr. Richard Spaide, from Vitreous Retina Macula Consultants of New York, has proposed that the rapid elevation of VEGF levels leads to the occurrence of such phenomena, including increased vascular permeability and leakage, not only in the neovascular lesion but also in the surrounding retinal vessels. If this hypothesis is valid, it underscores the potential benefit of ang-2 inhibition in the treatment of type 3 MNV, as it suggests that enhancing overall retinal vessel stability, rather than solely focusing on neovascular lesion suppression, could be of substantial advantage.
1.3 Why is an Additional Treat-and-Extend Study Utilizing Faricimab Deemed Necessary? The treat-and-extend regimen is widely acknowledged as a highly effective and efficient treatment approach for type 3 MNV, and it is extensively utilized in industrialized countries. In the TENEYA and LUCERNE clinical trials, conducted to evaluate the introduction of faricimab, personalized treatment intervals (PTIs) were employed for treatment, and starting from the second year, a treatment approach similar to treat-and-extend was implemented.
This approach offers a better reflection of treatment patterns in real-world settings compared to the fixed-dosing regimen utilized in previous clinical trials for the introduction of other anti-VEGF agents. Moreover, as suggested by Khanani et al., it may maximize the benefits of angiopoietin-2 blockade. However, it still differs slightly from the treat-and-extend approach commonly employed in actual clinical practice. Furthermore, in the case of type 3 MNV where undertreatment can have severe detrimental effects on the prognosis, the approach of extending injection intervals by 4 weeks, as utilized in the TENAYA and LUCERNE studies, may not be appropriate. It is deemed necessary to consider a more stringent injection extension approach with intervals of 2 weeks.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
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[General]
[Ocular]
Exclusion Criteria:
[General]
[Ocular]
Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intravitreal faricimab injection
* Initial loading injections : every 4 weeks by 12weeks * Treat and extend injection(\~76 week) : Week 20 - Week 76 TAE is initiated with a minimum injection interval of 8 weeks. If no recurrence is observed, the interval is extended by 2 weeks at a time, up to a maximum of 16 weeks. In the event of recurrence, the injection interval is reduced to 8 weeks, regardless of the previous schedule. The minimum injection interval remains 8 weeks.
Change in CST (central subfield thickness)
Change in central retinal thickness, as measured by optical coherence tomography, from baseline to week 76
Time frame: Baseline to week 76
Change in best-corrected visual acuity (BCVA)
Change in BCVA from baseline to week 76
Time frame: Baseline to week 76
Choroidal thickness
Change in choroidal thickness from baseline to week 76
Time frame: Baseline to week 76
Geographic atrophy (GA) development
Proportion of eyes experiencing development of GA from baseline to week 76
Time frame: Baseline to week 76
Fluid resolution
Proportion of eyes experiencing complete resolution of retinal fluids at week 20, 52, and 76
Time frame: Week 20, 52, and 76
Presence of neovascularization
Proportion of patients with neovascularization at baseline, week 20, 52, and 76
Time frame: Baseline, week 20, 52, and 76
Number of injection
Total number of injections from baseline to week 76
Time frame: Baseline to week 76
Maximum injection interval
Proportion of patients achieved 12 weeks and 16 weeks injection interval
Time frame: Baseline to 76 weeks
Adverse event
Proportion of patients experiencing adverse event during study period
Time frame: Baseline to week 76
Plan to share: No
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Studies of the drug tested here: Faricimab
Kim's Eye Hospital