Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-10-01

Brief Summary

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This is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with nAMD.

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Detailed Description

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Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.

Conditions

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Neovascular Age-Related Macular Degeneration (nAMD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

Interventions

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AXT107 0.1 mg

Single intravitreal injection of AXT107 0.1 mg/eye (low dose)

Intervention Type DRUG

AXT107 0.25 mg

Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)

Intervention Type DRUG

AXT107 0.5 mg

Single intravitreal injection of AXT107 0.5 mg/eye (high dose)

Intervention Type DRUG

Other Intervention Names

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Gersizangatide Gersizangatide Gersizangatide

Eligibility Criteria

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Inclusion Criteria

* Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed inform consent

Exclusion Criteria

* Macular edema or CMV secondary to any causes other than AMD in the study eye
* Previously-treated patients who are not responders to anti-VEGF
* Any condition that may preclude improvement in visual acuity in the study eye
* Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No