Clincosm LogoSign in Get a demo

Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME

Sponsor
AiViva BioPharma, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05698329
Collaborator
(none)
30
Enrollment
1
Location
4
Arms
25
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of the Safety, Pharmacokinetics, and Exploratory Efficacy of Periocular Administration of AIV007 in Subjects With Macular Edema Secondary to Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
Anticipated Study Start Date :
Mar 7, 2023
Anticipated Primary Completion Date :
Feb 6, 2025
Anticipated Study Completion Date :
Apr 6, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AIV007 Treatment Dose 1

Periocular injection, Dose 1

Drug: AIV007
Periocular injection
Experimental: AIV007 Treatment Dose 2

Periocular injection, Dose 2

Drug: AIV007
Periocular injection
Experimental: AIV007 Treatment Dose 3

Periocular injection, Dose 3

Drug: AIV007
Periocular injection
Experimental: AIV007 Treatment Dose 4

Periocular injection, Dose 4

Drug: AIV007
Periocular injection

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [Approximately 168 days]

    Incidence of adverse events and serious adverse events

Secondary Outcome Measures

  1. Mean change from baseline in BCVA [Approximately 168 days]

    Number of ETDRS letters

  2. Mean change from baseline in central subfield thickness as measured by OCT [Approximately 168 days]

    OCT read by a central reading center

  3. Mean time to rescue medication [Approximately 168 days]

    number of days to receive rescue medication

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
General inclusion Criteria:

  1. Male or female subjects aged 21-90 years (inclusive) at screening

  2. BCVA in the study eye at screening and baseline/Day 1: ETDRS letter score ≤ 75 and ≥ 24 (20/32 to 20/330 Snellen equivalent)

  3. Subject must have received treatment within the 24 months before screening with intravitreal (IVT) injections of an anti-VEGF agent with the last anti-VEGF injection in the study eye being at least 6 weeks (42 days) before baseline/Day 1.

  4. Subject has documentation of anti-VEGF responsiveness

  5. Subject must provide written informed consent before any study-related procedures are performed

  6. Clear ocular media and adequate pupil dilation in both eyes to permit good-quality photographic imaging

nAMD subject

  1. The active CNV is confirmed by FA (evidence of leakage)

  2. Residual intraretinal or subretinal fluid based on SD-OCT

  3. CST ≥ 300 µm as assessed by SD-OCT

  4. Total lesion size < 10 disc areas (25.4 mm2)

  5. Absence of geographic atrophy within 200 µm of the fovea

  6. If subretinal hemorrhage is present, it must be < 50% of the total CNV lesion and/or not involve the fovea

  7. If fibrosis is present, it must be <50% of the total lesion area

DME subject

  1. Diagnosis of diabetes mellitus (Type 1 or Type 2)

  2. Subject has clinically significant DME with central involvement (CST≥300 μm by OCT)

  3. The decrease in vision in the study eye was determined by the investigator to be primarily the result of DME

Exclusion Criteria:

  1. Previous treatment for nAMD or DME in the study eye other than standard-of-care anti-VEGF IVT injection, e.g., cell therapy, brachytherapy, gene therapy

  2. Uncontrolled IOP, defined as an IOP > 25 mmHg

  3. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) >10% at screening visit

  4. The spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (before cataract or refractive surgery) per the current prescription

  5. Any history of active bacterial, viral, fungal, or parasitic ocular or periocular infection, or intraocular inflammation in either eye within the 30 days before the screening Visit

  6. History of vitreous hemorrhage within 3 months before screening in the study eye

  7. Uncontrolled systemic disease or any other condition or therapy that would make the participant unsuitable for the study

  8. Participation in any investigational study within 60 days before the screening visit, or planned use of an investigational product or device during the study; any exposure to a prior investigational drug product must be fully washed out (at least 5 half-lives)

  9. History of allergy or hypersensitivity to constituents of the study treatment formulation, topical iodine, ocular antimicrobial solutions, or clinically relevant hypersensitivity to fluorescein

Contacts and Locations

Locations

Site City State Country Postal Code
1 Retina Consultants of Austin Austin Texas United States 78705

Sponsors and Collaborators

  • AiViva BioPharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AiViva BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT05698329
Other Study ID Numbers:
  • AIV007-E02
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Wet Macular Degeneration
Edema

Study Results

No Results Posted as of Jan 26, 2023