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AIV007 for Age-Related Macular Degeneration/Diabetic Macular Edema

Phase 1
Recruiting
Research Sponsored by AiViva BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 168 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety, how it works in the body, and how long it lasts for people with AMD or DME.

Who is the study for?
This trial is for adults aged 21-90 with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). Participants must have had previous anti-VEGF treatments and show responsiveness. Exclusions include uncontrolled eye pressure, severe myopia, recent ocular infections or inflammations, poorly controlled diabetes, and hypersensitivity to study treatment components.
What is being tested?
The trial tests the safety and effectiveness of a gel suspension called AIV007 administered around the eye in patients with nAMD or DME. It aims to understand how long the drug's effects last and how it moves through the body after being given.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the injection site, increased intraocular pressure, infection risk due to periocular administration, allergic responses to ingredients in AIV007 gel suspension.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 168 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 168 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Secondary study objectives
Mean change from baseline in best-corrected visual acuity (BCVA)
Mean change from baseline in central subfield thickness as measured by spectral domain optical coherence tomography (SD-OCT)
Mean time to rescue medication

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: AIV007 low doseExperimental Treatment1 Intervention
Periocular injection, low dose
Group II: AIV007 intermediate dose 3Experimental Treatment1 Intervention
Periocular injection, intermediate dose 3
Group III: AIV007 intermediate dose 2Experimental Treatment1 Intervention
Periocular injection, intermediate dose 2
Group IV: AIV007 intermediate dose 1Experimental Treatment1 Intervention
Periocular injection, intermediate dose 1
Group V: AIV007 High doseExperimental Treatment1 Intervention
Periocular injection, high dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AIV007
2020
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

AiViva BioPharma, Inc.Lead Sponsor
5 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

AIV007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05698329 — Phase 1
Diabetic Macular Edema Research Study Groups: AIV007 intermediate dose 1, AIV007 low dose, AIV007 High dose, AIV007 intermediate dose 3, AIV007 intermediate dose 2
Diabetic Macular Edema Clinical Trial 2023: AIV007 Highlights & Side Effects. Trial Name: NCT05698329 — Phase 1
AIV007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698329 — Phase 1
~1 spots leftby Feb 2025
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