Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization

NCT07187804 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-07-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Change in CST (central subfield thickness)

  Change in central retinal thickness, as measured by optical coherence tomography, from baseline to week 76

  Baseline to week 76

Secondary Outcomes (8)

• Change in best-corrected visual acuity (BCVA)

  Baseline to week 76

• Choroidal thickness

  Baseline to week 76

• Geographic atrophy (GA) development

  Baseline to week 76

• Fluid resolution

  Week 20, 52, and 76

• Presence of neovascularization

  Baseline, week 20, 52, and 76

Study Arms (1)

Faricimab treatment arm

EXPERIMENTAL

Drug: Intravitreal faricimab injection

Interventions

Intravitreal faricimab injection DRUG

* 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.

Faricimab treatment arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[General\]
• 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)
• \[Ocular\]
• 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

You may not qualify if:

• \[General\]
• 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
• 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.

Sponsors & Collaborators

• Kim's Eye Hospital: lead

Study Sites (1)

Kim's Eye Hospital

Seoul, 150-034, South Korea

Location

Related Publications (15)

• 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.

  PMID: 36246941 RESULT

• Spaide 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.

  PMID: 30550528 RESULT

• Kim 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.

  PMID: 23317655 RESULT

• Heier 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.

  PMID: 35085502 RESULT

• Kim 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.

  PMID: 33136977 RESULT

• Su 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.

  PMID: 28005662 RESULT

• Kim 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.

  PMID: 36977322 RESULT

• Kim 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.

  PMID: 29019795 RESULT

• Kim 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.

  PMID: 30581602 RESULT

• Kim 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.

  PMID: 30136868 RESULT

• Kim 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.

  PMID: 30918819 RESULT

• Chang 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.

  PMID: 25981599 RESULT

• Kim 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.

  PMID: 29979454 RESULT

• Yannuzzi 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.

  PMID: 11642370 RESULT

• Freund 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.

  PMID: 18301024 RESULT

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jae Hui Kim, M.D.

CONTACT

+82-1577-2639; kimoph@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 23, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 22, 2028
• Study Completion (Estimated): September 22, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)