Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration

NCT04422899 | Completed Phase 1 FDA Drug

• 1 other identifier: AIV007-E01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence of adverse events

  approximately 224 days

Secondary Outcomes (3)

• Mean change from baseline in BCVA

  approximately 224 days

• Mean change from baseline in central subfield thickness as measured by optical coherence tomography

  approximately 224 days

• Mean time to rescue medication (administration of anti-VEGF medication)

  approximately 224 days

Study Arms (3)

AIV007 Treatment Dose 1

EXPERIMENTAL

Intravitreal, Dose 1

Drug: AIV007

AIV007 Treatment Dose 2

EXPERIMENTAL

Intravitreal, Dose 2

Drug: AIV007

AIV007 Treatment Dose 3

EXPERIMENTAL

Intravitreal, Dose 3

Drug: AIV007

Interventions

AIV007 DRUG

intravitreal

AIV007 Treatment Dose 1; AIV007 Treatment Dose 2; AIV007 Treatment Dose 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead

Study Sites (2)

Salehi Retina Institute

Huntington Beach, California, 92647, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Study Design

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

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: August 28, 2020
• Primary Completion: September 29, 2021
• Study Completion: February 28, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (2)