Neovascular Age-related Macular DegenerationPhase 1nAMDNCT04422899
Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration
A Phase 1 study testing AIV007 in people with Neovascular Age-related Macular Degeneration, run by AiViva BioPharma, Inc. at 2 sites in United States.
Trial summary
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration 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?
- AIV007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2020to 28 Feb 2022
- 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 aged ≥ 50 years
- Subjects must provide written informed consent before any study-related procedures are performed
- Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent
- BCVA in the study eye
- Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse
- All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)
- Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging
Who cannot join
- Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy
- Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline
- Presence of diabetic retinopathy or glaucoma in either eye
- Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)
- Presence of active infection or inflammation within 30 days prior to screening
- Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline
- Uncontrolled hypertension or diabetes mellitus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Salehi Retina Institute
Huntington Beach, California, 92647
About this study
Official title: A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
Read the detailed description
AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 \& -3); fibroblast growth factor receptors (FGFR-1, -2, -3 \& -4); and platelet-derived growth factor receptors (PDGFR-α \& β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.
- Being tested
- AIV007
- Keywords
- Neovascular Age-Related Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIV007Drug
intravitreal
| Study group | Role | What they receive |
|---|---|---|
| AIV007 Treatment Dose 1 | Experimental | Intravitreal, Dose 1 Receives: Drug: AIV007 |
| AIV007 Treatment Dose 2 | Experimental | Intravitreal, Dose 2 Receives: Drug: AIV007 |
| AIV007 Treatment Dose 3 | Experimental | Intravitreal, Dose 3 Receives: Drug: AIV007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence of adverse events
Measured: approximately 224 days
Secondary outcomes (3)
Mean change from baseline in BCVA
Number of ETDRS letters
Measured: approximately 224 days
Mean change from baseline in central subfield thickness as measured by optical coherence tomography
OCT read by a central reading center
Measured: approximately 224 days
Mean time to rescue medication (administration of anti-VEGF medication)
Measured: approximately 224 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start28 Aug 2020
- Primary completion29 Sep 2021
- Study completion28 Feb 2022
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422899
- Sponsor's protocol ID
- AIV007-E01
- Acronym
- nAMD
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2020
- Last updated
- 27 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04422899
- Acronym / sponsor ID
- nAMD / AIV007-E01
- Keywords
- Neovascular Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 9 Jun 2020 (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.
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
Detailed description
AIV007 is a multiple kinase inhibitor of vascular endothelial growth factor receptors (VEGFR 1, -2 \& -3); fibroblast growth factor receptors (FGFR-1, -2, -3 \& -4); and platelet-derived growth factor receptors (PDGFR-α \& β)1. Lenvatinib is the active pharmaceutical ingredient in AIV007 formulation that is FDA-approved for oral administration for patients with advanced renal cell carcinoma (RCC), differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced endometrial carcinoma (Lenvima USPI 2021; NDA 206947). AIV007 is a novel, thermoresponsive gel suspension for intravitreal administration proposed to form a durable depot inside the eye. This monotherapy is being evaluated for the treatment of retinal and choroidal vascular disease. A single intravitreal treatment in 3 subjects was evaluated using 2 doses to evaluate depot formation, safety and biological activity by measuring visual acuity, reduction in retinal fluids associated with vision and effects of fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIV007 Treatment Dose 1 | Experimental | Drug: AIV007Intravitreal, Dose 1 |
| AIV007 Treatment Dose 2 | Experimental | Drug: AIV007Intravitreal, Dose 2 |
| AIV007 Treatment Dose 3 | Experimental | Drug: AIV007Intravitreal, Dose 3 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged ≥ 50 years
- Subjects must provide written informed consent before any study-related procedures are performed
- Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent
- BCVA in the study eye
- Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging
Key exclusion criteria (7 listed)
- Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy
- Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline
- Presence of diabetic retinopathy or glaucoma in either eye
- Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)
- Presence of active infection or inflammation within 30 days prior to screening
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 |
|---|---|---|
| AIV007intravitreal | Drug | AIV007 Treatment Dose 1, AIV007 Treatment Dose 2, AIV007 Treatment Dose 3 |
Primary outcome
Adverse Events
Time frame: approximately 224 days
Incidence of adverse events
3 secondary outcomes
Mean change from baseline in BCVA
Time frame: approximately 224 days
Mean change from baseline in central subfield thickness as measured by optical coherence tomography
Time frame: approximately 224 days
Mean time to rescue medication (administration of anti-VEGF medication)
Time frame: approximately 224 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 27 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.
2 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 AIV007 in people with Neovascular Age-related Macular Degeneration, run by AiViva BioPharma, Inc. at 2 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 7 inclusion and 7 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 27 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 2 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?
Adverse Events (time frame: approximately 224 days). 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 27 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.