Status:
COMPLETED
Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration
Lead Sponsor:
AiViva BioPharma, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04422899
Start Date
August 28 2020
End Date
February 28 2022
Last Update
December 27 2024
Active Locations (2)
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1
Salehi Retina Institute
Huntington Beach, California, United States, 92647
2
Retina Research Institute of Texas
Abilene, Texas, United States, 79606