Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME

Diabetic Macular Edema Clinical Trial

Official title:

A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 in Subjects With Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698329
• Other study ID #: AIV007-E02
• Status: Recruiting
• Phase: Phase 1
• Start date: March 2, 2023
• Est. completion date: April 6, 2025

Study information

• Verified date: January 2024
• Source: AiViva BioPharma, Inc.
• Contact: Darlene Deecher, PhD
• Phone: 9496621949
• Email: office[@]aiviva.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 6, 2025
• Est. primary completion date: February 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

General inclusion Criteria:

1. Male or female subjects aged 21-90 years (inclusive) at screening

2. BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score = 75 and = 24 (20/32 to 20/330 Snellen equivalent)

3. Subject must have received treatment within the 24 months before screening with intravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGF injection in the study eye being at least 6 weeks (42 days) before baseline/Day 1.

4. Subject has documentation of anti-VEGF responsiveness

5. Subject must provide written informed consent before any study-related procedures are performed

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

nAMD subject

1. The active CNV is confirmed by FA (evidence of leakage)

2. Residual intraretinal or subretinal fluid based on SD-OCT

3. CST = 300 µm as assessed by SD-OCT

4. Total lesion size < 10 disc areas (25.4 mm2)

5. Absence of geographic atrophy within 200 µm of the fovea

6. If subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/or not involve the fovea

7. If fibrosis is present, it must be <50% of the total lesion area

DME subject

1. Diagnosis of diabetes mellitus (Type 1 or Type 2)

2. Subject has clinically significant DME with central involvement (CST=300 µm by OCT)

3. The decrease in vision in the study eye was determined by the investigator to be primarily the result of DME

Exclusion Criteria:

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

2. Uncontrolled IOP, defined as an IOP > 25 mmHg

3. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visit

4. The spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (before cataract or refractive surgery) per the current prescription

5. Any history of active bacterial, viral, fungal, or parasitic ocular or periocular infection, or intraocular inflammation in either eye within the 30 days before the screening Visit

6. History of vitreous hemorrhage within 3 months before screening in the study eye

7. Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study

8. Participation in any investigational study within 60 days before the screening visit, or planned use of an investigational product or device during the study; any exposure to a prior investigational drug product must be fully washed out (at least 5 half-lives)

9. History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Related Conditions & MeSH terms

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

Intervention

Drug:
• AIV007
Periocular injection

Locations

Country	Name	City	State
United States	Retina Consultants of Austin	Austin	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 and serious adverse events	Approximately 168 days
Secondary	Mean change from baseline in best-corrected visual acuity (BCVA)	Number of Early Treatment Diabetic Retinopathy Study (ETDRS) letters	Approximately 168 days
Secondary	Mean change from baseline in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT)	SD-OCT read by a central reading center	Approximately 168 days
Secondary	Mean time to rescue medication	number of days to receive rescue medication	Approximately 168 days