Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

NCT05698329 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AIV007-E02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Macular Edema

Keywords

Anti-VEGF inhibitor; nAMD; Macular edema; DME; periocular; drug depot

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence of adverse events and serious adverse events

  Approximately 168 days

Secondary Outcomes (3)

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

  Approximately 168 days

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

  Approximately 168 days

• Mean time to rescue medication

  Approximately 168 days

Study Arms (6)

AIV007 low dose

EXPERIMENTAL

Periocular injection, low dose

Drug: AIV007

AIV007 intermediate dose 1

EXPERIMENTAL

Periocular injection, intermediate dose 1

Drug: AIV007

AIV007 intermediate dose 2

EXPERIMENTAL

Periocular injection, intermediate dose 2

Drug: AIV007

AIV007 intermediate dose 3

EXPERIMENTAL

Periocular injection, intermediate dose 3

Drug: AIV007

AIV007 intermediate dose 4

EXPERIMENTAL

Periocular injection, intermediate dose 4

Drug: AIV007

AIV007 High dose

EXPERIMENTAL

Periocular injection, high dose

Drug: AIV007

Interventions

AIV007 DRUG

Periocular injection

AIV007 High dose; AIV007 intermediate dose 1; AIV007 intermediate dose 2; AIV007 intermediate dose 3; AIV007 intermediate dose 4; AIV007 low dose

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging
• nAMD subject
• The active CNV is confirmed by 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

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (6)

Retina-Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Orange County Retina

Santa Ana, California, 92705, United States

Location

Verum Research

Eugene, Oregon, 97401, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Texas Retina Associates

Plano, Texas, 75075, United States

Location

Medical Center Ophthalmology

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Route of administration is by delivering single injection of AIV007 in the periocular tissue anatomically juxtasclearal where by the drug depot forms and delivers active agent over time.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: March 2, 2023
• Primary Completion: March 3, 2025
• Study Completion: April 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)