Wet Age-related Macular Degeneration (wAMD)NCT06718816
Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD
An observational study of Wet Age-related Macular Degeneration (wAMD), run by Beijing Anlong Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration (wAMD)
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to 30 Jun 2029
- 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: Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.
Who may be able to join
- The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
- The subjects are willing and able to follow planned visits and procedures.
Who cannot join
- None
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, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, Beijing Municipality
YouxinChen, +86-010-65296358, chenyouxinpumch@163.com
About this study
Official title: A Long-term Follow-up Study to Evaluate the Safety and Effectivity of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Mecular Degeneration (wAMD)
This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.
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 |
|---|---|---|
| The subjects received AL-001 ophthalmic injection | Evaluate long-term safety and efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE/SAE
Incidence and severity of ophthalmic and systematic AE/SAE.
Measured: month 48
Secondary outcomes (2)
Best Corrected Visual Acuity(BCVA)
Change in BCVA from baseline
Measured: month 48
The mean and frequency of anti-VEGF injections
The mean and frequency of subjects with wAMD receiving anti-VEGF injections
Measured: month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Dec 2024 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular Degeneration (wAMD)Studies of the same condition, open and under way.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anlong Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718816
- Sponsor's protocol ID
- AL-001-LT
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study to Evaluate the Safety and Effectivity of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Mecular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT06718816
- Acronym / sponsor ID
- AL-001-LT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Beijing Anlong Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 5 Dec 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.
This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The subjects received AL-001 ophthalmic injection | – | –Evaluate long-term safety and efficacy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled in AL-001-01 study and received AL-001 ophthalmic injection.
Key inclusion criteria (3 listed)
- The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
- The subjects are willing and able to follow planned visits and procedures.
Key exclusion criteria (1 listed)
- None
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
AE/SAE
Time frame: month 48
Incidence and severity of ophthalmic and systematic AE/SAE.
2 secondary outcomes
Best Corrected Visual Acuity(BCVA)
Time frame: month 48
The mean and frequency of anti-VEGF injections
Time frame: month 48
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 5 Dec 2024.
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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.
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 Wet Age-related Macular Degeneration (wAMD), run by Beijing Anlong Biopharmaceutical Co., Ltd. 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Dec 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.
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 AnlongBio (+86-010-80414166, info@anlongbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE/SAE (time frame: month 48). 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 5 Dec 2024.