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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 168 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 168 days
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition responds to anti-VEGF treatment.I have diabetes and significant eye swelling affecting my vision.I haven't had eye infections or inflammation recently.I have received treatments other than anti-VEGF injections for nAMD or DME in my study eye.My diabetes is not well-managed (HbA1c over 10%).I am between 21 and 90 years old.I do not have any health conditions that would interfere with the study.My eyes can be clearly photographed after being dilated.I've had eye injections for VEGF within the last 2 years, with the last one over 6 weeks ago.My eye condition involves active blood vessel growth and fluid under the retina without major scarring or damage near the center of my vision.
Research Study Groups:
This trial has the following groups:- Group 1: AIV007 intermediate dose 1
- Group 2: AIV007 low dose
- Group 3: AIV007 High dose
- Group 4: AIV007 intermediate dose 3
- Group 5: AIV007 intermediate dose 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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