Age-related Macular Degeneration (ARMD)Phase 4NCT07187804
Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization
A Phase 4 study testing Intravitreal faricimab injection in people with Age-related Macular Degeneration (ARMD) and Choroidal Neovascularization, run by Kim's Eye Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration (ARMD), Choroidal Neovascularization, Anti-vascular Endothelial Growth Factor
- What is being tested?
- Intravitreal faricimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2025to 22 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [General]
- Signed Informed Consent Form
- Age > 50 years at the time of signing Informed Consent Form
- Participants who are able to comply with the study protocol, in the investigator's judgment
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)
- [Ocular]
Show all 9Show fewer
- BCVA that is equal or higher than 24 Early Treatment Diabetic Retinopathy Study letters on Screening Day/ Day 0.
- Confirmed diagnosis, by the investigator, of symptomatic type 3 neovascularization based on sufficiently clear ocular media and adequate pupillary dilatation allowing acquisition of good quality retinal images for confirmation.
- Treatment naive participants
Who cannot join
- [General]
- Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
- Any major illness or major surgical procedure within 1 month before screening
- Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 (Grade Group of 1) and a stable prostate-specific antigen for >12 months
- Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)
- Systemic treatment for suspected or active systemic infection on study Day 1
Show all 31Show fewer
- Uncontrolled blood pressure, defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg while the participant is at rest on study Day 1
- History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
- History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab
- [Ocular]
- Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
- Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
- Any history of uveitis in either eye.
- Presence of definite chorioretional anastomosis
- Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible macular neovascularization.)
- Scar or fibrosis, making up > 50% of total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
- Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.
- Prior vitrectomy in the study eye
- Any history of macular hole of stage 2 and above in the study eye.
- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
- Prior trabeculectomy or other filtration surgery in the study eye.
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
- Active intraocular inflammation in either eye.
- Active ocular or periocular infection in either eye.
- Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Kim's Eye Hospital
Seoul, 150-034
Jae Hui Kim, M.D., +82-1577-2639, kimoph@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Age-related Macular Degeneration (ARMD), Choroidal Neovascularization, Anti-vascular Endothelial Growth Factor
- Being tested
- Intravitreal faricimab injection
- Keywords
- Age-related macular degeneration, Type 3 macular neovascularization, Retinal angiomatous proliferation, Faricimab, Treat and extend
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal faricimab injectionDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Faricimab treatment arm | Experimental | Not described Receives: Drug: Intravitreal faricimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CST (central subfield thickness)
Change in central retinal thickness, as measured by optical coherence tomography, from baseline to week 76
Measured: Baseline to week 76
Secondary outcomes (8)
Change in best-corrected visual acuity (BCVA)
Change in BCVA from baseline to week 76
Measured: Baseline to week 76
Choroidal thickness
Change in choroidal thickness from baseline to week 76
Measured: Baseline to week 76
Geographic atrophy (GA) development
Proportion of eyes experiencing development of GA from baseline to week 76
Measured: Baseline to week 76
Fluid resolution
Proportion of eyes experiencing complete resolution of retinal fluids at week 20, 52, and 76
Measured: Week 20, 52, and 76
Presence of neovascularization
Proportion of patients with neovascularization at baseline, week 20, 52, and 76
Measured: Baseline, week 20, 52, and 76
Number of injection
Total number of injections from baseline to week 76
Measured: Baseline to week 76
Maximum injection interval
Proportion of patients achieved 12 weeks and 16 weeks injection interval
Measured: Baseline to 76 weeks
Adverse event
Proportion of patients experiencing adverse event during study period
Measured: Baseline to week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start23 Sep 2025 (estimated)
- Primary completion22 Sep 2028 (estimated)
- Study completion22 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Age-related Macular Degeneration (ARMD)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kim's Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hui Kim, Kim's Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187804
- Sponsor's protocol ID
- 2025-07-004
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.
PubMed 36246941Spaide RF. NEW PROPOSAL FOR THE PATHOPHYSIOLOGY OF TYPE 3 NEOVASCULARIZATION AS BASED ON MULTIMODAL IMAGING FINDINGS. Retina. 2019 Aug;39(8):1451-1464. doi: 10.1097/IAE.0000000000002412.
PubMed 30550528Kim JH, Kim JR, Kang SW, Kim SJ, Ha HS. Thinner choroid and greater drusen extent in retinal angiomatous proliferation than in typical exudative age-related macular degeneration. Am J Ophthalmol. 2013 Apr;155(4):743-9, 749.e1-2. doi: 10.1016/j.ajo.2012.11.001. Epub 2013 Jan 11.
PubMed 23317655Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
PubMed 35085502Kim JH, Kim JW, Kim CG, Lee DW. LONG-TERM CHANGES IN CHOROIDAL THICKNESS IN EYES WITH TYPE 3 MACULAR NEOVASCULARIZATION. Retina. 2021 Jun 1;41(6):1251-1258. doi: 10.1097/IAE.0000000000003010.
PubMed 33136977Su D, Lin S, Phasukkijwatana N, Chen X, Tan A, Freund KB, Sarraf D. AN UPDATED STAGING SYSTEM OF TYPE 3 NEOVASCULARIZATION USING SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY. Retina. 2016 Dec;36 Suppl 1:S40-S49. doi: 10.1097/IAE.0000000000001268.
PubMed 28005662Kim JH, Kim JW, Kim CG. INCIDENCE AND TIMING OF PIGMENT EPITHELIAL DETACHMENT AND SUBRETINAL FLUID DEVELOPMENT IN TYPE 3 MACULAR NEOVASCULARIZATION ASSOCIATED WITH AGE-RELATED MACULAR DEGENERATION. Retina. 2023 Aug 1;43(8):1264-1273. doi: 10.1097/IAE.0000000000003797.
PubMed 36977322Kim JH, Chang YS, Kim JW, Kim CG, Lee DW, Cho SY. DIFFERENCE IN TREATMENT OUTCOMES ACCORDING TO OPTICAL COHERENCE TOMOGRAPHY-BASED STAGES IN TYPE 3 NEOVASCULARIZATION (RETINAL ANGIOMATOUS PROLIFERATION). Retina. 2018 Dec;38(12):2356-2362. doi: 10.1097/IAE.0000000000001876.
PubMed 29019795Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Prechoroidal Cleft in Type 3 Neovascularization: Incidence, Timing, and Its Association with Visual Outcome. J Ophthalmol. 2018 Nov 19;2018:2578349. doi: 10.1155/2018/2578349. eCollection 2018.
PubMed 30581602Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Early Recurrent Hemorrhage in Submacular Hemorrhage Secondary to Type 3 Neovascularization or Retinal Angiomatous Proliferation: Incidence and Influence on Visual Prognosis. Semin Ophthalmol. 2018;33(6):820-828. doi: 10.1080/08820538.2018.1511814. Epub 2018 Aug 23.
PubMed 30136868Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Abrupt visual loss during anti-vascular endothelial growth factor treatment for type 3 neovascularization. Int J Ophthalmol. 2019 Mar 18;12(3):480-487. doi: 10.18240/ijo.2019.03.20. eCollection 2019.
PubMed 30918819Chang YS, Kim JH, Yoo SJ, Lew YJ, Kim J. Fellow-eye neovascularization in unilateral retinal angiomatous proliferation in a Korean population. Acta Ophthalmol. 2016 Feb;94(1):e49-53. doi: 10.1111/aos.12748. Epub 2015 May 17.
PubMed 25981599Kim JH, Chang YS, Kim JW, Kim CG, Lee DW, Kim HS. LONG-TERM VISUAL CHANGES IN INITIALLY STRONGER FELLOW EYES IN PATIENTS WITH UNILATERAL TYPE 3 NEOVASCULARIZATION. Retina. 2019 Sep;39(9):1672-1681. doi: 10.1097/IAE.0000000000002239.
PubMed 29979454Yannuzzi LA, Negrao S, Iida T, Carvalho C, Rodriguez-Coleman H, Slakter J, Freund KB, Sorenson J, Orlock D, Borodoker N. Retinal angiomatous proliferation in age-related macular degeneration. Retina. 2001;21(5):416-34. doi: 10.1097/00006982-200110000-00003.
PubMed 11642370Freund KB, Ho IV, Barbazetto IA, Koizumi H, Laud K, Ferrara D, Matsumoto Y, Sorenson JA, Yannuzzi L. Type 3 neovascularization: the expanded spectrum of retinal angiomatous proliferation. Retina. 2008 Feb;28(2):201-11. doi: 10.1097/IAE.0b013e3181669504.
PubMed 18301024
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization
- ClinicalTrials.gov ID
- NCT07187804
- Acronym / sponsor ID
- 2025-07-004
- Conditions
- Age-related Macular Degeneration (ARMD), Choroidal Neovascularization, Anti-vascular Endothelial Growth Factor
- Keywords
- Age-related macular degeneration, Type 3 macular neovascularization, Retinal angiomatous proliferation, Faricimab, Treat and extend
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kim's Eye HospitalUniversity, hospital or other
- Study start
- 23 Sep 2025 (estimated)
- Primary completion
- 22 Sep 2028 (estimated)
- Study completion
- 22 Sep 2028 (estimated)
- First posted
- 23 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Faricimab treatment arm | Experimental | Drug: Intravitreal faricimab injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- [General]
- Signed Informed Consent Form
- Age > 50 years at the time of signing Informed Consent Form
- Participants who are able to comply with the study protocol, in the investigator's judgment
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)
Key exclusion criteria (31 listed)
- [General]
- Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
- Any major illness or major surgical procedure within 1 month before screening
- Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 (Grade Group of 1) and a stable prostate-specific antigen for >12 months
- Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)
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 |
|---|---|---|
| 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. | Drug | Faricimab treatment arm |
Primary outcome
Change in CST (central subfield thickness)
Time frame: Baseline to week 76
Change in central retinal thickness, as measured by optical coherence tomography, from baseline to week 76
8 secondary outcomes
Change in best-corrected visual acuity (BCVA)
Time frame: Baseline to week 76
Choroidal thickness
Time frame: Baseline to week 76
Geographic atrophy (GA) development
Time frame: Baseline to week 76
Fluid resolution
Time frame: Week 20, 52, and 76
Presence of neovascularization
Time frame: Baseline, week 20, 52, and 76
Number of injection
Time frame: Baseline to week 76
Maximum injection interval
Time frame: Baseline to 76 weeks
Adverse event
Time frame: Baseline to week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 36246941Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.
- Results publication: PubMed 30550528Spaide RF. NEW PROPOSAL FOR THE PATHOPHYSIOLOGY OF TYPE 3 NEOVASCULARIZATION AS BASED ON MULTIMODAL IMAGING FINDINGS. Retina. 2019 Aug;39(8):1451-1464. doi: 10.1097/IAE.0000000000002412.
- Results publication: PubMed 23317655Kim JH, Kim JR, Kang SW, Kim SJ, Ha HS. Thinner choroid and greater drusen extent in retinal angiomatous proliferation than in typical exudative age-related macular degeneration. Am J Ophthalmol. 2013 Apr;155(4):743-9, 749.e1-2. doi: 10.1016/j.ajo.2012.11.001. Epub 2013 Jan 11.
- Results publication: PubMed 35085502Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
- Results publication: PubMed 33136977Kim JH, Kim JW, Kim CG, Lee DW. LONG-TERM CHANGES IN CHOROIDAL THICKNESS IN EYES WITH TYPE 3 MACULAR NEOVASCULARIZATION. Retina. 2021 Jun 1;41(6):1251-1258. doi: 10.1097/IAE.0000000000003010.
- Results publication: PubMed 28005662Su D, Lin S, Phasukkijwatana N, Chen X, Tan A, Freund KB, Sarraf D. AN UPDATED STAGING SYSTEM OF TYPE 3 NEOVASCULARIZATION USING SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY. Retina. 2016 Dec;36 Suppl 1:S40-S49. doi: 10.1097/IAE.0000000000001268.
- Results publication: PubMed 36977322Kim JH, Kim JW, Kim CG. INCIDENCE AND TIMING OF PIGMENT EPITHELIAL DETACHMENT AND SUBRETINAL FLUID DEVELOPMENT IN TYPE 3 MACULAR NEOVASCULARIZATION ASSOCIATED WITH AGE-RELATED MACULAR DEGENERATION. Retina. 2023 Aug 1;43(8):1264-1273. doi: 10.1097/IAE.0000000000003797.
- Results publication: PubMed 29019795Kim JH, Chang YS, Kim JW, Kim CG, Lee DW, Cho SY. DIFFERENCE IN TREATMENT OUTCOMES ACCORDING TO OPTICAL COHERENCE TOMOGRAPHY-BASED STAGES IN TYPE 3 NEOVASCULARIZATION (RETINAL ANGIOMATOUS PROLIFERATION). Retina. 2018 Dec;38(12):2356-2362. doi: 10.1097/IAE.0000000000001876.
- Results publication: PubMed 30581602Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Prechoroidal Cleft in Type 3 Neovascularization: Incidence, Timing, and Its Association with Visual Outcome. J Ophthalmol. 2018 Nov 19;2018:2578349. doi: 10.1155/2018/2578349. eCollection 2018.
- Results publication: PubMed 30136868Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Early Recurrent Hemorrhage in Submacular Hemorrhage Secondary to Type 3 Neovascularization or Retinal Angiomatous Proliferation: Incidence and Influence on Visual Prognosis. Semin Ophthalmol. 2018;33(6):820-828. doi: 10.1080/08820538.2018.1511814. Epub 2018 Aug 23.
- Results publication: PubMed 30918819Kim JH, Chang YS, Kim JW, Kim CG, Lee DW. Abrupt visual loss during anti-vascular endothelial growth factor treatment for type 3 neovascularization. Int J Ophthalmol. 2019 Mar 18;12(3):480-487. doi: 10.18240/ijo.2019.03.20. eCollection 2019.
- Results publication: PubMed 25981599Chang YS, Kim JH, Yoo SJ, Lew YJ, Kim J. Fellow-eye neovascularization in unilateral retinal angiomatous proliferation in a Korean population. Acta Ophthalmol. 2016 Feb;94(1):e49-53. doi: 10.1111/aos.12748. Epub 2015 May 17.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal faricimab injection in people with Age-related Macular Degeneration (ARMD) and Choroidal Neovascularization, run by Kim's Eye Hospital at 1 site in South Korea.
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 9 inclusion and 31 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: opening soon, as of the sponsor's last update on 23 Sep 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae Hui Kim, M.D. (+82-1577-2639, kimoph@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CST (central subfield thickness) (time frame: Baseline to week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07187804, which also lists 15 linked publications.
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 23 Sep 2025.