Search > Age-Related Macular Degeneration
35 Participants NeededMy employer runs this trial

AIV007 for Age-Related Macular Degeneration

Recruiting at 1 trial location
DC
DD
Overseen ByDiane DS Tang-Liu, PHD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AiViva BioPharma, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile.

Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.

Are You a Good Fit for This Trial?

This trial is for people with wet age-related macular degeneration in one eye who have already responded to previous anti-VEGF treatments. Their vision must be better than 20/200 in the study eye, and they need to meet certain eye health criteria and follow all study rules.

Inclusion Criteria

Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent)
I have active abnormal blood vessel growth in my eye due to nAMD.
Central subfield thickness in the study eye of less than or equal to 370 microns
See 3 more

Exclusion Criteria

My study eye has been treated with cell, gene, or brachytherapy before.
My study eye has less than 30 µm of intraretinal fluid.
I have had major eye surgery or a corneal transplant in the study eye recently.
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • AIV007

Trial Overview

The study compares a new periocular injection called AIV007 to standard Eylea injections for treating wet age-related macular degeneration. Participants are randomly assigned to receive either treatment and are monitored monthly.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: AIV007Experimental Treatment1 Intervention
Group II: Group 1: AIV007Experimental Treatment1 Intervention
Group III: Group 3: EyleaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AiViva BioPharma, Inc.

Lead Sponsor

Trials
6
Recruited
90+

ClinDatrix, Inc.

Industry Sponsor

Trials
5
Recruited
160+

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