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

Completed · Phase 1

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT04422899

Run by

AiViva BioPharma, Inc.

People needed

3

Starts

2020-08-28

Expected to finish

2022-02-28

Last updated by the study team

2024-12-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Salehi Retina Institute — Huntington Beach, California, United States
• Retina Research Institute of Texas — Abilene, Texas, United States

Full record on ClinicalTrials.gov

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