Clinical trial NCT06572553: Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
Official title: Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Age-Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Keywords: Age-Related Macular Degeneration
Faricimab
Diabetic Macular Edema
Retinal Vein Occlusion
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1. Chinese patients aged 18 years or older ;
2. Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
3. Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
4. Patients who have received at least one treatment with faricimab during the course of the study;
5. have signed an informed consent form.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if drug Faricimab works to treat nAMD, DME or RVO in adults. It will also learn about the safety of drug Faricimab. The main questions it aims to answer are:

Does drug Faricimab can improve the best-corrected visual acuity of participants? What medical problems do participants have when inject drug Faricimab? Participants will inject drug Faricimab every month for 3 months. Visit the clinic once every 2 weeks for checkups.

Detailed description: Intravitreal anti-vascular endothelial growth factor (VEGF) therapies are used to treat retinal vascular diseases such as neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). However, the clinical effectiveness of such therapies is often suboptimal, often resulting in poor treatment adherence due to the burden of frequent monitoring and injection therapy (every 4-8 weeks). Different approaches have been investigated to improve outcomes in such diseases, including modification of dosing regimens to reduce treatment burden and continued research to identify new drug targets. Angiopoietin-2 (Ang-2) has been implicated in the pathogenesis of several retinal vascular diseases, including nAMD and DME, and has therefore been identified as a potential new target.

Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech. Dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease. Faricimab is administered via intravitreal injection. It is the first bispecific antibody designed for intraocular use. In January 2022, faricimab was approved in the United States for the treatment of participants with nAMD or DME. And in March 2024, faricimab began to be approved for use in the treatment of patients in our clinic.

Therefore, investigators collected participants who were injected with Faricimab in the clinic and conducted follow-up visits to evaluate the therapeutic efficacy and application prospect of Faricimab in the clinic.

Eligibility criteria: Inclusion Criteria:

1. Chinese patients aged 18 years or older and of any gender;
2. Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
3. Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
4. Patients who have received at least one treatment with faricimab during the course of the study;
5. have signed an informed consent form.

Exclusion Criteria:

1. Active ocular inflammation or suspected active ocular infection in either eye;
2. Receipt of any other anti-VEGF therapy after faricimab;
3. Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;
4. Currently participating in any other clinical trial.

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: through study completion, an average of 3 months.
Secondary outcomes:
measure: central retinal thickness (CRT)
timeFrame: through study completion, an average of 3 months.
measure: Choroidal neovascularization (CNV)
timeFrame: through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Panpan Ye, doctor
role: STUDY_DIRECTOR
References:
citation: Ferro Desideri L, Traverso CE, Nicolo M, Munk MR. Faricimab for the Treatment of Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration. Pharmaceutics. 2023 May 5;15(5):1413. doi: 10.3390/pharmaceutics15051413.
citation: Stanga PE, Valentin-Bravo FJ, Stanga SEF, Reinstein UI, Pastor-Idoate S, Downes SM. Faricimab in neovascular AMD: first report of real-world outcomes in an independent retina clinic. Eye (Lond). 2023 Oct;37(15):3282-3289. doi: 10.1038/s41433-023-02505-z. Epub 2023 Mar 23.
citation: Giancipoli E, Guglielmi A, Bux AV, Clima GME, Pignatelli F, Boscia F, Viggiano P, Boscia G, Fortunato F, Besozzi G, Niro A, Dore S, Iaculli C. Real-World Outcomes of a Loading Phase with Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration (n-AMD) and Diabetic Macular Edema (DME). Ophthalmol Ther. 2024 Aug;13(8):2163-2184. doi: 10.1007/s40123-024-00980-5. Epub 2024 Jun 4.