Effect of Intravitreally Administered AIV007 in Subjects With nAMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422899
• Other study ID #: AIV007-E01
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: September 2020
• Source: AiViva BioPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 28, 2022
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• AIV007
intravitreal

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AiViva BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of adverse events	approximately 224 days
Secondary	Mean change from baseline in BCVA	Number of ETDRS letters	approximately 224 days
Secondary	Mean change from baseline in central subfield thickness as measured by optical coherence tomography	OCT read by a central reading center	approximately 224 days
Secondary	Mean time to escape medication		approximately 224 days