Neovascular Age-related Macular DegenerationPhase 1NCT05345769
Safety and Efficacy of AM712 in Patients with NAMD
A Phase 1 study testing AM712(ASKG712) in people with Neovascular Age-related Macular Degeneration, run by AffaMed Therapeutics Limited at 9 sites in United States.
Trial summary
The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (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
- What is being tested?
- AM712(ASKG712)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Apr 2022to 4 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female subjects with 50 years of age or older
- Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
- The area of CNV must occupy at least 50% of total lesion
- Total lesion area ≤ 12 DA
- ETDRS BCVA letter score measured at screening and baseline
- Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye
Who cannot join
- Any previous systemic anti-VEGF treatment
- Any systemic treatment or therapy to treat neovascular AMD
- Continuous use of systemic corticosteroids
- Diseases that affect intravenous injection and venous blood sampling
- Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye
- History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.
Show all 14Show fewer
- The area of fibrosis occupies ≥ 50% of total lesion area in study eye
- Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
- History or any concurrent macular abnormality other than AMD in study eye
- Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
- History of recurrent inflammation in study eye
- History of treatment for nAMD
- Subject having out of range laboratory values defined as:
- ALT or AST > 2 x ULN, total bilirubin > 1.5 x ULN Serum creatinine > 1.5 x ULN, BUN > 2 x ULN HbA1c > 7.5% at screening
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Retina Consultants of Texas
Bellaire, Texas, 77401
Colorado Retina
Lakewood, Colorado, 80228
Florida Eye Associates
Melbourne, Florida, 32901
Tennessee Retina, PC
Nashville, Tennessee, 37203
Retina Consultants San Diego
Poway, California, 92064
Retina Consultants of Texas
San Antonio, Texas, 78240
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts, 01107
Retina Consultants of Texas
The Woodlands, Texas, 77384
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: A Prospective, Multi-Center, Open-label, Sequential, Multiple Ascending-Dose and High Concentration Cohorts Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AM712 Following Intravitreal Administration in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
Read the detailed description
The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.
Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.
The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.
- Being tested
- AM712(ASKG712)
- Keywords
- nAMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM712(ASKG712)Biological
AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.
| Study group | Role | What they receive |
|---|---|---|
| Phase I- All | Experimental | Subjects with neovascular AMD Receives: Biological: AM712(ASKG712) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular adverse events (AEs) of the study eyes
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Measured: 252 days
Incidence of non-ocular AEs
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Measured: 252 days
Any relevant safety observations derived from BCVA
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Measured: 252 days
Any relevant safety observations derived from SD-OCT
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Measured: 252 days
Secondary outcomes (4)
Mean change from baseline in central subfield thickness as assessed by SD-OCT
To evaluate the efficacy of AM712 in Subjects with nAMD
Measured: 252 days
Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT
To evaluate the efficacy of AM712 in Subjects with nAMD
Measured: 252 days
Mean change from baseline in BCVA (ETDRS)
To evaluate the efficacy of AM712 in Subjects with nAMD
Measured: 252 days
Proportion of patients gaining ≥ 15 letters from baseline BCVA
To evaluate the efficacy of AM712 in Subjects with nAMD
Measured: 252 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start28 Apr 2022
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
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 DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AffaMed Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345769
- Sponsor's protocol ID
- AM712E1001
- Status last verified
- Nov 2024
- First submitted
- 12 Apr 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Open-label, Sequential, Multiple Ascending-Dose and High Concentration Cohorts Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AM712 Following Intravitreal Administration in Patients with Neovascular Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT05345769
- Acronym / sponsor ID
- AM712E1001
- Keywords
- nAMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AffaMed Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 26 Apr 2022 (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.
The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
Detailed description
The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.
Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.
The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I- All | Experimental | Biological: AM712(ASKG712)Subjects with neovascular AMD |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects with 50 years of age or older
- Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
- The area of CNV must occupy at least 50% of total lesion
- Total lesion area ≤ 12 DA
- ETDRS BCVA letter score measured at screening and baseline
Key exclusion criteria (14 listed)
- Any previous systemic anti-VEGF treatment
- Any systemic treatment or therapy to treat neovascular AMD
- Continuous use of systemic corticosteroids
- Diseases that affect intravenous injection and venous blood sampling
- Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in 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 |
|---|---|---|
| AM712(ASKG712)AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2. | Biological | Phase I- All |
Primary outcome
Incidence of ocular adverse events (AEs) of the study eyes
Time frame: 252 days
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Incidence of non-ocular AEs
Time frame: 252 days
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Any relevant safety observations derived from BCVA
Time frame: 252 days
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Any relevant safety observations derived from SD-OCT
Time frame: 252 days
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
4 secondary outcomes
Mean change from baseline in central subfield thickness as assessed by SD-OCT
Time frame: 252 days
Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT
Time frame: 252 days
Mean change from baseline in BCVA (ETDRS)
Time frame: 252 days
Proportion of patients gaining ≥ 15 letters from baseline BCVA
Time frame: 252 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AM712(ASKG712) in people with Neovascular Age-related Macular Degeneration, run by AffaMed Therapeutics Limited at 9 sites in United States.
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 6 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: finished, as of the sponsor's last update on 12 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 9 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of ocular adverse events (AEs) of the study eyes (time frame: 252 days). The study lists 4 primary outcomes in all. 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 Dec 2024.