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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
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

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
Age-Related Macular Degeneration Research Study Groups: AIV007 low dose, AIV007 High dose, AIV007 intermediate dose 3, AIV007 intermediate dose 2, AIV007 intermediate dose 1
Age-Related Macular Degeneration 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the potential risks of administering AIV007 Treatment Dose 1 to patients?

"AIV007 Treatment Dose 1 received a score of 1 on the safety scale due to its Phase 1 status, meaning there is preliminary data supporting both efficacy and safety."

Answered by AI

Is there any availability for individuals to join this clinical trial?

"Per the information available on clinicaltrials.gov, this particular trial is no longer actively searching for patients. It was initially posted on March 7th 2023 and has not been updated since January 16th of that same year. However, there are currently 274 other medical studies looking for volunteers to participate in them."

Answered by AI

What are the requirements for participation in this trial?

"This medical trial seeks 30 individuals aged 21 to 90 that are currently suffering from age-related macular degeneration. Additional requirements include: an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 24 and 75, a history of being treated with intravitreal injections within the last two years, documentation of anti-VEGF responsiveness, signed informed consent prior to any study procedures, clear ocular media for good quality imaging, active choroidal neovascularization confirmed by fluorescein angiography (FA), residual intraretinal or subretinal fluid as seen on spectral domain optical coherence"

Answered by AI

Do octogenarians qualify for participation in this clinical investigation?

"As noted in the eligibility requirements, participants of this medical trial must be between 21 and 90 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME
2023. "Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05698329.
All > Macular Edema > Wet Macular Degeneration
~12 spots leftby Feb 2025
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