Wet Age-related Macular Degeneration (wAMD)Phase 1/2NCT06707753
Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD
A Phase 1/2 study testing AL-001 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 I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Wet Age-related Macular Degeneration (wAMD)
- What is being tested?
- AL-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2023to 31 Aug 2025
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 50 and ≤ 80.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
- 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.
About this study
Official title: An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics 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 receive a single dose of AL-001 administered via suprachoroidal space injection.
- Being tested
- AL-001
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.
| Study group | Role | What they receive |
|---|---|---|
| AL-001 Dose 1 | Experimental | Injection of low dose Receives: Drug: AL-001 |
| AL-001 Dose 2 | Experimental | Injection of medium dose Receives: Drug: AL-001 |
| AL-001 Dose 3 | Experimental | Injection of high dose Receives: Drug: AL-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Week 24
Secondary outcomes (1)
Evaluate the effect of AL-001 on BCVA
Mean change from baseline in BCVA
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start11 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT06707753
- Sponsor's protocol ID
- AL-001-01
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2024
- Last updated
- 19 Mar 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT06707753
- Acronym / sponsor ID
- AL-001-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Beijing Anlong Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 27 Nov 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 Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics 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 receive a single dose of AL-001 administered via suprachoroidal space injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-001 Dose 1 | Experimental | Drug: AL-001Injection of low dose |
| AL-001 Dose 2 | Experimental | Drug: AL-001Injection of medium dose |
| AL-001 Dose 3 | Experimental | Drug: AL-001Injection of high dose |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥ 50 and ≤ 80.
- The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
- 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, AL-001 Dose 3 |
Primary outcome
Safety and tolerability
Time frame: Week 24
Incidence of adverse events (AEs) and serious adverse events (SAEs)
1 secondary outcome
Evaluate the effect of AL-001 on BCVA
Time frame: Week 52
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 19 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AL-001 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Safety and tolerability (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 19 Mar 2025.