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Neovascular Age-related Macular DegenerationPhase 1NCT05698329

Effect of AIV007 by Periocular Administration in Subjects With Macular Edema Secondary to nAMD and DME

A Phase 1 study testing AIV007 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by AiViva BioPharma, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
AIV007
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
6 sitesUnited States
Study dates
2 Mar 2023to 3 Mar 2025
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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion Criteria:
  • Male or female subjects aged 21-90 years (inclusive) at screening
  • BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent)
  • Subject must have received treatment within the 24 months before screening with intravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGF injection in the study eye being at least 6 weeks (42 days) before baseline/Day 1.
  • Subject has documentation of anti-VEGF responsiveness
  • Subject must provide written informed consent before any study-related procedures are performed
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  • Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging
  • nAMD subject
  • The active choroidal neovascularization (CNV) is confirmed by fluorescein angiography (FA; evidence of leakage)
  • Residual intraretinal or subretinal fluid based on SD-OCT
  • CST ≥ 300 µm as assessed by SD-OCT
  • Total lesion size < 10 disc areas (25.4 mm2)
  • Absence of geographic atrophy within 200 µm of the fovea
  • If subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/or not involve the fovea
  • If fibrosis is present, it must be <50% of the total lesion area
  • DME subject
  • Diagnosis of diabetes mellitus (Type 1 or Type 2)
  • Subject has clinically significant DME with central involvement (CST≥300 μm by OCT)
  • The decrease in vision in the study eye was determined by the investigator to be primarily the result of DME

Who cannot join

  • Previous treatment for nAMD or DME in the study eye other than standard-of-care anti-VEGF IVT injection, e.g., cell therapy, brachytherapy, gene therapy
  • Uncontrolled intraocular pressure (IOP), defined as an IOP > 25 mmHg
  • Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visit
  • The spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (before cataract or refractive surgery) per the current prescription
  • Any history of active bacterial, viral, fungal, or parasitic ocular or periocular infection, or intraocular inflammation in either eye within the 30 days before the screening Visit
  • History of vitreous hemorrhage within 3 months before screening in the study eye
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  • Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study
  • Participation in any investigational study within 60 days before the screening visit, or planned use of an investigational product or device during the study; any exposure to a prior investigational drug product must be fully washed out (at least 5 half-lives)
  • History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Retina-Vitreous Associates

    Beverly Hills, California, 90211

  • Verum Research

    Eugene, Oregon, 97401

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Texas Retina Associates

    Plano, Texas, 75075

  • Medical Center Ophthalmology

    San Antonio, Texas, 78240

  • Orange County Retina

    Santa Ana, California, 92705

Other trials in United States

About this study

Official title: A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 in Subjects With Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

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.

. AiViva BioPharma, Inc. (AiViva) has developed a novel, thermoresponsive gel suspension of AIV007 for periocular administration to form a durable depot. This monotherapy is in development for the treatment of retinal and choroidal vascular disease (i.e., neovascular age-related macular degeneration (nAMD) \& diabetic macular edema (DME)). For preclinical and clinical (AIV007-E02) studies using periocular administration, AIV007 is injected outside the eyeball and the depot forms a soft mass, referred to as posterior juxtascleral depot (PJD) placement.

Being tested
AIV007
Keywords
Anti-VEGF inhibitor, nAMD, Macular edema, DME, periocular, drug depot
Medical subject headings
Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIV007Drug

    Periocular injection

Study groups in NCT05698329
Study groupRoleWhat they receive
AIV007 low doseExperimentalPeriocular injection, low dose
Receives: Drug: AIV007
AIV007 intermediate dose 1ExperimentalPeriocular injection, intermediate dose 1
Receives: Drug: AIV007
AIV007 intermediate dose 2ExperimentalPeriocular injection, intermediate dose 2
Receives: Drug: AIV007
AIV007 intermediate dose 3ExperimentalPeriocular injection, intermediate dose 3
Receives: Drug: AIV007
AIV007 intermediate dose 4ExperimentalPeriocular injection, intermediate dose 4
Receives: Drug: AIV007
AIV007 High doseExperimentalPeriocular injection, high dose
Receives: Drug: AIV007

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Incidence of adverse events and serious adverse events

    Measured: Approximately 168 days

Secondary outcomes (3)

  1. Mean change from baseline in best-corrected visual acuity (BCVA)

    Number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters

    Measured: Approximately 168 days

  2. Mean change from baseline in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT)

    SD-OCT read by a central reading center

    Measured: Approximately 168 days

  3. Mean time to rescue medication

    number of days to receive rescue medication

    Measured: Approximately 168 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start2 Mar 2023
  3. Primary completion3 Mar 2025
  4. Study completion3 Mar 2025

Resources

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
Model description
Route of administration is by delivering single injection of AIV007 in the periocular tissue anatomically juxtascleral where by the drug depot forms and delivers active agent over time.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698329
Sponsor's protocol ID
AIV007-E02
Status last verified
Nov 2026
First submitted
16 Jan 2023
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AIV007 in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by AiViva BioPharma, Inc. at 6 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 19 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 168 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698329.

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 4 Nov 2026.

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