Wet Age-related Macular Degeneration (wAMD)Phase 2NCT06839339
Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD
A Phase 2 study testing AL-001 and Aflibercept in people with Wet Age-related Macular Degeneration (wAMD), run by Beijing Anlong Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Wet Age-related Macular Degeneration (wAMD)
- What is being tested?
- AL-001 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 30 Jan 2027
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 50 and ≤ 85.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- The study eye has response to anti-VEGF injections.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
Who cannot join
- Non-wAMD induced CNV or macular edema in the study eye.
- Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
- Uncontrolled glaucoma in the study eye.
- History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
- Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
- Ametropia (high myopia or high hyperopia) > 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
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- Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
- None of intraocular inflammation in the study eye.
- Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
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
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing
Youxin Chen, +86-010-65296358, chenyouxinpumch@163.com
About this study
Official title: A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
- Being tested
- AL-001, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-001Drug
Administered via suprachoroidal space injection.
AfliberceptDrug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| AL-001 Dose 1 | Experimental | Injection of dose 1 Receives: Drug: AL-001 |
| AL-001 Dose 2 | Experimental | Injection of dose 2 Receives: Drug: AL-001 |
| Aflibercept | Active comparator | Intravitreal injection Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of AL-001 on BCVA
Change in BCVA
Measured: Week 24
Secondary outcomes (2)
Safety
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Week 56
Evaluate the effect of AL-001 on central retinal thickness (CRT)
Mean change from baseline in CRT as measured
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start18 Feb 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jan 2027 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT06839339
- Sponsor's protocol ID
- AL-001-02
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Positive-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Single Suprachoroidal Space Injection of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT06839339
- Acronym / sponsor ID
- AL-001-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Anlong Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 21 Feb 2025 (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 Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-001 Dose 1 | Experimental | Drug: AL-001Injection of dose 1 |
| AL-001 Dose 2 | Experimental | Drug: AL-001Injection of dose 2 |
| Aflibercept | Active comparator | Drug: AfliberceptIntravitreal injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥ 50 and ≤ 85.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- The study eye has response to anti-VEGF injections.
- The subject or their legal representative agrees to participate in this study and signs a written ICF.
Key exclusion criteria (9 listed)
- Non-wAMD induced CNV or macular edema in the study eye.
- Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
- Uncontrolled glaucoma in the study eye.
- History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
- Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
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 |
|---|---|---|
| AL-001Administered via suprachoroidal space injection. | Drug | AL-001 Dose 1, AL-001 Dose 2 |
| AfliberceptIntravitreal injection | Drug | Aflibercept |
Primary outcome
Evaluate the effect of AL-001 on BCVA
Time frame: Week 24
Change in BCVA
2 secondary outcomes
Safety
Time frame: Week 56
Evaluate the effect of AL-001 on central retinal thickness (CRT)
Time frame: Week 56
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 21 Feb 2025.
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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?
A Phase 2 study testing AL-001 and Aflibercept in people with 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 4 inclusion and 9 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 21 Feb 2025. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anlong Bio (+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?
Evaluate the effect of AL-001 on BCVA (time frame: Week 24). 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 21 Feb 2025.