Effect of Intravitreally Administered AIV007 in Subjects With nAMD

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AiViva BioPharma, Inc.

Criteria

Inclusion Criteria:

1. Male or female subjects aged ≥ 50 years

2. Subjects must provide written informed consent before any study-related procedures are performed

3. 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

4. BCVA in the study eye

1. Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse

2. All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)

5. Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging

Exclusion Criteria:

1. Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy

2. Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline

3. Presence of diabetic retinopathy or glaucoma in either eye

4. Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)

5. Presence of active infection or inflammation within 30 days prior to screening

6. 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

7. Uncontrolled hypertension or diabetes mellitus