Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Trial ID: 2023-506707-25-00
Protocol: CR44829
Sponsor: F. Hoffmann-La Roche AG

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Diseases & Conditions

Choroidal neovascularisation

Objectives

The primary objective of this study is to evaluate the efficacy of intravitreal injections of faricimab compared to ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. This evaluation is clinically significant for determining the therapeutic effectiveness of the investigational agent in managing this specific retinal condition. Secondary objectives include:

Assessment of efficacy regarding best-corrected visual acuity outcomes.
Comparison of the frequency of administration between the two treatments.
Evaluation of anatomic outcomes using optical coherence tomography.
Evaluation of anatomic outcomes using color fundus photography or fundus fluorescein angiography.
Assessment of the safety profile of faricimab compared to ranibizumab.
Evaluation of the immune response to faricimab.

Participants

This clinical trial involves 190 participants diagnosed with choroidal neovascularization secondary to pathologic myopia. The study population includes both male and female patients within specific age categories. Eligible subjects must be treatment-naïve and exhibit active myopic choroidal neovascularization confirmed via ocular examination. The primary objectives are:

To evaluate the efficacy of intravitreal injections of faricimab compared with ranibizumab.

Inclusion requires a best-corrected visual acuity between 78 and 24 letters per the ETDRS protocol. Participants must demonstrate at least one specific lesion type, including subfoveal, juxtafoveal, extrafoveal, or peripapillary involvement of the central macular area. Additionally, subjects must possess sufficiently clear ocular media and adequate pupillary dilatation for retinal imaging. Participants must be overtly healthy as determined by medical history, physical examination, and laboratory testing.

Plans and Procedures

This Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluates the efficacy and safety of faricimab compared to ranibizumab. The investigation focuses on patients with choroidal neovascularization secondary to pathologic myopia. The trial design involves intravitreal injections to assess changes in best-corrected visual acuity and central subfield thickness. The research methodology includes a screening process to confirm diagnosis via ocular examination and verify medical history, physical examination, and laboratory tests. Following the initial visit, participants undergo a series of follow-up assessments to monitor treatment response and safety endpoints, including the incidence of ocular and non-ocular adverse events. The study design aims to measure the proportion of patients gaining or avoiding loss of vision and the total number of injections required over time. The overall duration of the study is estimated to conclude by December 31, 2026.

Treatment

The investigational medicinal product is faricimab. This substance is administered via intravitreal injection at a dose of 0.5 mg. The study aims to evaluate its efficacy and safety in patients with choroidal neovascularization secondary to pathologic myopia.

The comparator treatment consists of ranibizumab, provided as Lucentis 10 mg/ml solution for injection. This medication is administered via intravitreal use at a dose of 6 mg.

Efficacy

The primary efficacy endpoint is the change from baseline in Best Corrected Visual Acuity (BCVA) averaged over Weeks 4, 8, and 12. Secondary efficacy parameters include:

Change from baseline in BCVA over time.
Proportion of patients gaining $\ge$15 letters averaged over Weeks 4, 8, and 12.
Proportion of patients gaining $\ge$15 letters in BCVA from baseline over time.
Proportion of patients avoiding loss of $\ge$15 letters in BCVA from baseline over time.
Proportion of patients gaining $\ge$15 letters or achieving BCVA of $\ge$84 letters over time.
Proportion of patients with BCVA Snellen equivalent of 20/40 or better over time.
Proportion of patients with BCVA Snellen equivalent of 20/200 or worse over time.
Proportion of patients receiving only one intravitreal injection from baseline to Week 12, Week 24, and Week 48.
Number of intravitreal injections received by Week 12, Week 24, and Week 48.
Change from baseline in central subfield thickness (CST) of the study eye averaged over Weeks 4, 8, and 12, and change in CST over time.
Change from baseline in total area of choroidal neovascularization (CNV) lesion and total area of CNV leakage at Week 12 and Week 48.
Proportion of patients with absence of macular leakage at Week 12 and Week 48.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
Diagnosis of active myopic CNV in the study eye confirmed by ocular examination and CRC review
BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on Day 1
Presence of at least 1 of the following lesion types (determined by CRC): Subfoveal (presence of abnormal neovasculature in the avascular central fovea) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but ≤ 200 um from the center) with involvement of the central macular area Extrafoveal (presence of abnormal neovasculature > 200 um from the center of the fovea) with involvement of the central macular area Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area
Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis

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Exclusion Criteria

CNV due to causes other than pathologic myopia, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, or uveitis, etc
Any history of macular pathology unrelated to pathologic myopia affecting vision or contributing to the presence of intraretinal or subretinal fluid
Presence at screening of central serous chorioretinopathy or myopic tractional maculopathy. Retinal pigment epithelial tear involving the macula on Day 1
Non-functioning non-study eye, defined as either: BCVA Snellen equivalent of 20/200 or worse No physical presence of non-study eye (i.e., monocular)
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation (anterior, intermediate or posterior uveitis, grade trace or above) or suspected or active ocular or periocular infection in either eye on Day 1

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
France	Not Recruiting	01 Mar 2024	27
Germany	Not Recruiting	01 Mar 2024	10
Italy	Not Recruiting	01 Mar 2024	18
Poland	Not Recruiting	01 Mar 2024	19
Spain	Not Recruiting	01 Mar 2024	16