Neovascular Age-related Macular Degeneration(nAMD)NCT07581782
Prospective, Single Arm, Observational Study of Faricimab in the Treatment of Neovascular Age-related Macular Degeneration (nAMD)
An observational study of Neovascular Age-related Macular Degeneration(nAMD), run by Sun Yat-sen University at 1 site in China.
Trial summary
Evaluate the benefit of faricimab (4 loading doses + PRN) on best-corrected visual acuity in patients with nAMD. Evaluate the safety and anatomical improvement of faricimab (4 loading doses + PRN) in patients with nAMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration(nAMD)
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 May 2028
- Phase
- Observational
- 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
Study population: The study subjects were recruited from outpatients of the Medical Retina Department at Zhongshan Ophthalmic Center, and eligible cases meeting the study criteria were selected from the outpatient medical record system.
Who may be able to join
- Age ≥50 years, any gender.
- The study eye must have active treatment-naïve macular neovascularization (MNV) secondary to AMD, confirmed by the investigator based on OCT images showing the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) involving the fovea.
- The study eye must have a best-corrected visual acuity (BCVA) measured using the 4-meter ETDRS chart of 24-78 ETDRS letters (approximately Snellen equivalent 20/320 - 20/32).
- Central subfield thickness (CST) ≥300 μm.
- The study eye has sufficiently clear ocular media and adequate pupillary dilation.
- Women of childbearing potential must use contraceptive measures during the study treatment period and for at least 3 months after the last dose.
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- The patient and their legal representative are able to understand and sign the informed consent form, and are willing to comply with the follow-up and treatment plan specified in the study protocol.
- Patients with nAMD who have already been determined to receive the faricimab (4 loading doses + PRN) treatment regimen based on clinical need, for post-treatment observation.
- Only one eye will be selected as the study eye (if both eyes meet the criteria, the investigator will select the eye with worse visual acuity as the study eye).
Who cannot join
- Patients with ocular or periocular infection.
- Patients with active intraocular inflammation.
- Known hypersensitivity to faricimab or any of its excipients.
- Previous treatment with any other investigational therapy or any therapy that affects choroidal neovascularization (CNV) or macular neovascularization (MNV), or any therapy used for AMD.
- Presence of any ocular or systemic disease other than nAMD that may affect visual acuity assessment.
- Prior treatment in the study eye with anti-VEGF agents, corticosteroids, or laser therapy.
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- Structural damage to the fovea in the study eye that is likely to prevent BCVA improvement even after resolution of macular edema (e.g., retinal pigment epithelial atrophy, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates).
- Presence of retinal pigment epithelial tear involving the macula in the study eye at screening.
- Uncontrolled glaucoma in the study eye.
- Refractive error in the study eye with spherical equivalent exceeding 6 diopters of myopia.
- Any cataract surgery or steroid treatment for cataract surgery complications in the study eye within 6 months prior to screening.
- Pregnant or breastfeeding women.
- Patients considered unsuitable for study enrollment by the investigator for other reasons.
- Inability to provide baseline clinical data (BCVA, visual contrast sensitivity, indocyanine green angiography (ICGA) images, optical coherence tomography angiography (OCTA) images, OCT images, color fundus photography (CFP) images) within 2 weeks (14 days) prior to the first faricimab treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Evaluate the benefit of faricimab (4 loading doses + PRN) on best-corrected visual acuity in patients with nAMD. Evaluate the safety and anatomical improvement of faricimab (4 loading doses + PRN) in patients with nAMD.
Read the detailed description
This study is a prospective, single-arm, observational study designed to evaluate the efficacy and safety of faricimab (4 loading doses + PRN) in patients with neovascular age-related macular degeneration (nAMD). Patients first receive four intravitreal loading injections of faricimab (6 mg each) at 4-week intervals, followed by a pro re nata (PRN) treatment phase. The study assesses changes from baseline in best-corrected visual acuity (BCVA), contrast sensitivity, choroidal vascularity index (CVI), maximum pigment epithelial detachment (PED) height, and the proportion of patients with intraretinal fluid (IRF) / subretinal fluid (SRF) at weeks 4, 8, 12, 16, 24, and 48. The objective is to evaluate the visual benefit, anatomical improvement, and safety of faricimab (4 loading doses + PRN) in treating nAMD. The use of other anti-VEGF agents (systemic or ocular) is prohibited during the treatment period.
- Keywords
- Faricimab, Neovascular Age-related Macular Degeneration(nAMD), Choroidal Vascularity Index (CVI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neovascular Age-related Macular Degeneration(nAMD) Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal Vascularity Index (CVI)
CVI represents the proportion of the total choroidal area occupied by blood vessels (luminal area).
Measured: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Secondary outcomes (2)
visual contrast sensitivity
Visual contrast sensitivity is the ability to detect differences in luminance (brightness) between an object and its background.
Measured: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Height of pigment epithelial detachment
The vertical distance between the detached retinal pigment epithelium (RPE) and the underlying Bruch's membrane.
Measured: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration(nAMD)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581782
- Sponsor's protocol ID
- IIT2026006
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Observational Study of Faricimab in the Treatment of Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT07581782
- Acronym / sponsor ID
- IIT2026006
- Keywords
- Faricimab, Neovascular Age-related Macular Degeneration(nAMD), Choroidal Vascularity Index (CVI)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 12 May 2026 (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.
Evaluate the benefit of faricimab (4 loading doses + PRN) on best-corrected visual acuity in patients with nAMD. Evaluate the safety and anatomical improvement of faricimab (4 loading doses + PRN) in patients with nAMD.
Detailed description
This study is a prospective, single-arm, observational study designed to evaluate the efficacy and safety of faricimab (4 loading doses + PRN) in patients with neovascular age-related macular degeneration (nAMD). Patients first receive four intravitreal loading injections of faricimab (6 mg each) at 4-week intervals, followed by a pro re nata (PRN) treatment phase. The study assesses changes from baseline in best-corrected visual acuity (BCVA), contrast sensitivity, choroidal vascularity index (CVI), maximum pigment epithelial detachment (PED) height, and the proportion of patients with intraretinal fluid (IRF) / subretinal fluid (SRF) at weeks 4, 8, 12, 16, 24, and 48. The objective is to evaluate the visual benefit, anatomical improvement, and safety of faricimab (4 loading doses + PRN) in treating nAMD. The use of other anti-VEGF agents (systemic or ocular) is prohibited during the treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neovascular Age-related Macular Degeneration(nAMD) Group | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects were recruited from outpatients of the Medical Retina Department at Zhongshan Ophthalmic Center, and eligible cases meeting the study criteria were selected from the outpatient medical record system.
Key inclusion criteria (9 listed)
- Age ≥50 years, any gender.
- The study eye must have active treatment-naïve macular neovascularization (MNV) secondary to AMD, confirmed by the investigator based on OCT images showing the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) involving the fovea.
- The study eye must have a best-corrected visual acuity (BCVA) measured using the 4-meter ETDRS chart of 24-78 ETDRS letters (approximately Snellen equivalent 20/320 - 20/32).
- Central subfield thickness (CST) ≥300 μm.
- The study eye has sufficiently clear ocular media and adequate pupillary dilation.
Key exclusion criteria (14 listed)
- Patients with ocular or periocular infection.
- Patients with active intraocular inflammation.
- Known hypersensitivity to faricimab or any of its excipients.
- Previous treatment with any other investigational therapy or any therapy that affects choroidal neovascularization (CNV) or macular neovascularization (MNV), or any therapy used for AMD.
- Presence of any ocular or systemic disease other than nAMD that may affect visual acuity assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Choroidal Vascularity Index (CVI)
Time frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
CVI represents the proportion of the total choroidal area occupied by blood vessels (luminal area).
2 secondary outcomes
visual contrast sensitivity
Time frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Height of pigment epithelial detachment
Time frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
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 12 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chenjin Jin principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration(nAMD), run by Sun Yat-sen University 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 9 inclusion and 14 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 12 May 2026. 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.
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 Rongtian Chen (16619724130, 376126340@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal Vascularity Index (CVI) (time frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.