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Diabetic Macular EdemaNCT06439576

Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)

An observational study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, run by Hoffmann-La Roche at 41 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Faricimab
How many people
1,000 participants
Where
41 sitesChina
Study dates
9 May 2024to 15 Nov 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will recruit patients who are naïve to anti-VEGF therapy in the study eye and those who have previously been treated with anti-VEGF therapy in the study eye. Study participation of patients previously treated with other anti-VEGF agents will be capped at a maximum of 40% of each indication enrollment.

Who may be able to join

  • Have signed the informed consent
  • Female and male Chinese patients, who had been diagnosed with nAMD, DME, or RVO by CFP, OCT, FFA, ICGA, or OCTA
  • ≥50 years old for patients with nAMD, ≥18 years old both for patients with DME and RVO, at the time of signing informed consent (or the first administration of faricimab, whichever occurs first)
  • Patients for whom the decision to receive treatment with faricimab is made prior to and independent from study participation
  • Patients have received at least one faricimab treatment (the first dose) in the study eye

Who cannot join

  • Patients not receiving treatment for nAMD/DME/RVO with faricimab according to the standard of care and in line with the current summary of product characteristics (SPC) / labeling in China
  • Active ocular inflammation or suspected / active ocular infection in either eye
  • Received any other anti-VEGF treatment after faricimab
  • Received any steroid treatment within 6 months (180 days) before the first faricimab treatment in the study eye
  • Any participation in any other clinical trials currently
  • Patients could not provide the clinical data (visual acuity and OCT images) within 2 weeks (14 days) before receiving the initial faricimab injection

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

China41 sites

  • Peking University People's Hospital

    Beijing, 100044

  • The First People's Hospital of Chengdu

    Chengdu, Sichuan, 610016

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • People's Hospital of Dingzhou

    Dingzhou, 73000

  • Dongyang People's Hospital

    Dongyang, 322100

  • Fushun Eye Hospital

    Fushun, Liaoning, 110114

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060

  • Guizhou Provincial People's Hospital

    Guiyang, 550002

  • Eye Hospital of Shandong First Medical University

    Jinan, 250021

  • Jinhua municipal central hospital

    Jinhua, Zhejiang, 321083

  • The First People's Hospital of Kashgar

    Kashgar, Xinjiang Uygur, 844000

  • The First People's Hospital of Yunnan Province

    Kunming, Yun'nan, 650032

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, 730000

  • The First Affiliated Hospital of Henan UN of Science and Technology

    Luoyang, Henan, 471000

  • The Affiliated Hospital of Southwest Medical University, Zhongshan Campus

    Luzhou

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029

  • The People?s Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021

  • Panjin Central Hospital

    Panjin, Liaoning, 124010

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 265299

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092

  • Shanghai Zhoupu Hospital

    Shanghai

  • Joint Shantou International Eye Center

    Shantou, Guangdong, 515051

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shenyang Fourth People's Hospital

    Shenyang, 110031

  • Shenzhen Eye Hospital

    Shenzhen, 518040

  • Hebei People's Hospital

    Shijiazhuang, 050071

  • Taihe Hospital of Shiyan

    Shiyan, Hubei, 442000

  • Shanxi Bethune Hospital

    Taiyuan, 030032

  • Tianjin Eye Hospital

    Tianjin, 300050

  • Affiliated Hospital of Shandong Second Medical University

    Weifang, Shandong, 261031

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027

  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

    Wuhan, 430022

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • Xiamen Eye Center Of Xiamen University

    Xiamen, 361000

  • Hebei Eye Hospital

    Xingtai

  • Xuzhou No.1 Peoples Hospital

    Xuzhou, Jiangsu, 221002

  • Henan Provincial Eye Hosptial

    Zhengzhou, 450003

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563000

Other trials in China

About this study

Official title: China Faricimab Real World Evidence: Evaluation of Faricimab Effectiveness, Safety and Treatment Pattern, in Diabetic Macular Edema, Retinal Vein Occlusion and Neovascular Age-Related Macular Degeneration: The Farseeing Study

The Farseeing Study will explore long-term effectiveness, safety, and treatment patterns among patients being treated with faricimab in real-world, routine clinical practice in China. It is a primary data collection, non-interventional, prospective and retrospective, multi-center study designed to collect real-world, long-term data to gain clinical evidence on faricimab, by observing cohorts of patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) who are receiving treatment with faricimab.

Being tested
Faricimab
Medical subject headings
Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called VABYSMO®

    The dosing and treatment duration of the studied medicinal product is at the discretion of the physician in accordance with clinical practice and labeling in China.

Study groups in NCT06439576
Study groupRoleWhat they receive
Cohort 1: Patients with nAMDNot described
Receives: Drug: Faricimab
Cohort 2: Patients with DMENot described
Receives: Drug: Faricimab
Cohort 3: Patients with RVONot described
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Visual Acuity from Baseline at Month 12

    Visual acuity will be collected as measured per local practice and then will be converted to the approximate ETDRS letter score.

    Measured: Baseline and Month 12

Secondary outcomes (14)

  1. Visual Acuity Over Time

    Measured: Baseline, Months 3, 6, 9, 12, 18, and 24

  2. Change in Visual Acuity from Baseline Over Time

    Measured: Baseline, Months 3, 6, 9, 18, and 24

  3. Central Subfield Thickness Over Time

    Measured: Baseline, Months 3, 6, 9, 12, 18, and 24

  4. Change in Central Subfield Thickness from Baseline Over Time

    Measured: Baseline, Months 3, 6, 9, 12, 18, and 24

  5. Percentage of Eyes on Each Treatment Regimen (Fixed, Treat-and-Extend, As Needed, or Other)

    Measured: From Baseline to Month 24

  6. Number of Treatments per Year

    Measured: Months 12 and 24

  7. Percentage of Eyes with Treatment Switch by Reason for Switch Over Time

    Measured: Months 3, 6, 9, 12, 18, and 24

  8. Percentage of Eyes with Treatment Regimen Switch (Fixed, Treat-and-Extend, As Needed, or Other) by Reason for Switch Over Time

    Measured: Months 3, 6, 9, 12, 18, and 24

  9. Total Number of Visits per Year

    Measured: Months 12 and 24

  10. Number of Visits With or Without Treatment per Year

    Measured: Months 12 and 24

  11. Time Interval Between Treatments per Year

    Measured: Months 12 and 24

  12. Percentage of Eyes Treated with Ocular Concomitant Medications or Therapy by Type and Frequency During the Study

    Measured: From Baseline until end of study (up to 3.5 years)

  13. Number of Participants Lost to Follow-Up More Than 6 Months at Months 12, 18, and 24

    Measured: Months 12, 18, and 24

  14. Percentage of Eyes According to the Last Treatment Interval at Months 3, 6, 12, 18, and 24

    Measured: Months 3, 6, 12, 18, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start9 May 2024
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439576
Sponsor's protocol ID
ML45401
Status last verified
Nov 2026
First submitted
28 May 2024
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, run by Hoffmann-La Roche at 41 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Acuity from Baseline at Month 12 (time frame: Baseline and Month 12). 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 NCT06439576.

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 6 Nov 2026.

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