Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
NCT05698329 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2025-03-06
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).
Conditions
- Neovascular Age-related Macular Degeneration
- Diabetic Macular Edema
- Macular Edema
Interventions
- DRUG
-
AIV007
Periocular injection
Sponsors & Collaborators
-
AiViva BioPharma, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 21 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-02
- Primary Completion
- 2025-03-03
- Completion
- 2025-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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