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Effect of Intravitreally Administered AIV007 in Subjects With nAMD

Primary Purpose

Neovascular Age-related Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AIV007

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects aged ≥ 50 years
Subjects must provide written informed consent before any study-related procedures are performed
Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent
BCVA in the study eye
1. Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse
2. All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent)
Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging

Exclusion Criteria:

Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy
Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline
Presence of diabetic retinopathy or glaucoma in either eye
Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery)
Presence of active infection or inflammation within 30 days prior to screening
Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline
Uncontrolled hypertension or diabetes mellitus

Sites / Locations

Retina Research Institute of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

AIV007 Treatment Dose 1

AIV007 Treatment Dose 2

AIV007 Treatment Dose 3

Arm Description

Intravitreal, Dose 1

Intravitreal, Dose 2

Intravitreal, Dose 3

Outcomes

Primary Outcome Measures

Adverse Events

Incidence of adverse events

Secondary Outcome Measures

Mean change from baseline in BCVA

Number of ETDRS letters

Mean change from baseline in central subfield thickness as measured by optical coherence tomography

OCT read by a central reading center

Mean time to escape medication

Full Information

NCT ID

NCT04422899

First Posted

June 5, 2020

Last Updated

May 11, 2022

Sponsor

AiViva BioPharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04422899

Brief Title

Effect of Intravitreally Administered AIV007 in Subjects With nAMD

Official Title

A Phase I Study of the Safety, Pharmacokinetics, and Duration of Effect of Intravitreally Administered AIV007 Gel Suspension in Subjects With Neovascular Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

August 28, 2020 (Actual)

Primary Completion Date

September 29, 2021 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AiViva BioPharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIV007 Treatment Dose 1

Arm Type

Experimental

Arm Description

Intravitreal, Dose 1

Arm Title

AIV007 Treatment Dose 2

Arm Type

Experimental

Arm Description

Intravitreal, Dose 2

Arm Title

AIV007 Treatment Dose 3

Arm Type

Experimental

Arm Description

Intravitreal, Dose 3

Intervention Type

Drug

Intervention Name(s)

AIV007

Intervention Description

intravitreal

Primary Outcome Measure Information:

Title

Adverse Events

Description

Incidence of adverse events

Time Frame

approximately 224 days

Secondary Outcome Measure Information:

Title

Mean change from baseline in BCVA

Description

Number of ETDRS letters

Time Frame

approximately 224 days

Title

Mean change from baseline in central subfield thickness as measured by optical coherence tomography

Description

OCT read by a central reading center

Time Frame

approximately 224 days

Title

Mean time to escape medication

Time Frame

approximately 224 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged ≥ 50 years Subjects must provide written informed consent before any study-related procedures are performed Active subfoveal CNV in the study eye secondary to AMD that has previously been treated with at least 3 intravitreal injections of an anti-VEGF agent BCVA in the study eye Sentinel subjects only: 65 ETDRS letters (20/50 Snellen equivalent) or worse All other subjects: 78 to 35 ETDRS letters (20/32 to 20/200 Snellen equivalent) Clear ocular media and adequate pupil dilation in both eyes to permit good quality photographic imaging Exclusion Criteria: Previous treatment for nAMD in the study eye, other than standard-of-care anti- VEGF IVT injection, eg, cell therapy, brachytherapy, gene therapy Treatment with anti-VEGF in the non-study eye 2 weeks prior to baseline Presence of diabetic retinopathy or glaucoma in either eye Spherical equivalent for refractive error in the study eye of worse than 8.0 diopters of myopia (prior to cataract or refractive surgery) Presence of active infection or inflammation within 30 days prior to screening Presence of contraindications to anti-VEGF treatment, including myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke within the last 3 months of baseline Uncontrolled hypertension or diabetes mellitus

Facility Information:

Facility Name

Retina Research Institute of Texas

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

12. IPD Sharing Statement

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Effect of Intravitreally Administered AIV007 in Subjects With nAMD

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