Age-Related Macular DegenerationPhase 2/3NCT06572553
Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
A Phase 2/3 study testing Faricimab in people with Age-Related Macular Degeneration and Diabetic Macular Edema, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Faricimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Chinese patients aged 18 years or older and of any gender;
- Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
- Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
- Patients who have received at least one treatment with faricimab during the course of the study;
- have signed an informed consent form.
Who cannot join
- Active ocular inflammation or suspected active ocular infection in either eye;
- Receipt of any other anti-VEGF therapy after faricimab;
- Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;
- Currently participating in any other clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hanzhou, Zhejiang, 310000
Panpan Ye, doctor, +86 13806506267, yepanpan@zju.edu.cn
Ningxi Hong, master, +86 19550173720, 2218651@zju.edu.cn
About this study
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.
Read the 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.
- Being tested
- Faricimab
- Keywords
- Age-Related Macular Degeneration, Faricimab, Diabetic Macular Edema, Retinal Vein Occlusion
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech, and dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease relative to anti-VEGF therapy alone.
| Study group | Role | What they receive |
|---|---|---|
| Injection of faricimab | Experimental | Intervention: Intravitreal Injections Generic name: faricimab Dosage: 0.05ml (6mg) Frequency: every month Duration: 3 months Receives: Drug: Faricimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
BCVA will be measured at a standard distance of 4 metres under standardised lighting conditions (85-100 candela) by using an ETDRS optometer. Each eye will be tested separately with the participants who wear best corrected vision glasses. The smallest line of letters that the patient can correctly identify will be recorded as their BCVA.Measurements will be taken by trained ophthalmologists at baseline and at time points such as 2 weeks after the start of the trial and 1 month after the start of the trial to ensure consistency.
Measured: through study completion, an average of 3 months.
Secondary outcomes (2)
central retinal thickness (CRT)
Retinal thickness will be measured by using optical coherence tomography (OCT). Patients will undergo standardised retinal imaging, performed after pupil dilation. The average retinal thickness in and around the central sulcus will be measured using an automatically generated thickness map from the OCT device.
Measured: through study completion, an average of 3 months.
Choroidal neovascularization (CNV)
Choroidal neovascularisation was measured by OCT and OCTA. Standardised retinal imaging was performed after pupil dilation. Using the images provided by the OCT and OCTA devices, the presence or absence of accompanying choroidal neovascularisation was measured, and if present, the type was further determined
Measured: through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panpan Ye, doctor, Study director, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572553
- Sponsor's protocol ID
- 2024-0612
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Basic characteristics,multimodal imaging data
Publications
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.
PubMed 37242655Stanga 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.
PubMed 36959312Giancipoli 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.
PubMed 38831127
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
- ClinicalTrials.gov ID
- NCT06572553
- Acronym / sponsor ID
- 2024-0612
- Keywords
- Age-Related Macular Degeneration, Faricimab, Diabetic Macular Edema, Retinal Vein Occlusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 27 Aug 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Injection of faricimab | Experimental | Drug: FaricimabIntervention: Intravitreal Injections Generic name: faricimab Dosage: 0.05ml (6mg) Frequency: every month Duration: 3 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese patients aged 18 years or older and of any gender;
- Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
- Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
- Patients who have received at least one treatment with faricimab during the course of the study;
- have signed an informed consent form.
Key exclusion criteria (4 listed)
- Active ocular inflammation or suspected active ocular infection in either eye;
- Receipt of any other anti-VEGF therapy after faricimab;
- Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;
- Currently participating in any other clinical trial.
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 |
|---|---|---|
| FaricimabFaricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech, and dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease relative to anti-VEGF therapy alone. | Drug | Injection of faricimab |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: through study completion, an average of 3 months.
BCVA will be measured at a standard distance of 4 metres under standardised lighting conditions (85-100 candela) by using an ETDRS optometer. Each eye will be tested separately with the participants who wear best corrected vision glasses. The smallest line of letters that the patient can correctly identify will be recorded as their BCVA.Measurements will be taken by trained ophthalmologists at baseline and at time points such as 2 weeks after the start of the trial and 1 month after the start of the trial to ensure consistency.
2 secondary outcomes
central retinal thickness (CRT)
Time frame: through study completion, an average of 3 months.
Choroidal neovascularization (CNV)
Time frame: through study completion, an average of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 37242655Ferro 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.
- Background: PubMed 36959312Stanga 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.
- Background: PubMed 38831127Giancipoli 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.
- Individual participant dataSharing planned: No. Basic characteristics,multimodal imaging data
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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. This study is not recruiting at the moment.
Panpan Ye, doctor study director
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Faricimab in people with Age-Related Macular Degeneration and Diabetic Macular Edema, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panpan Ye, doctor (+86 13806506267, yepanpan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) (time frame: through study completion, an average of 3 months.). 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 NCT06572553, which also lists 3 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 27 Aug 2024.