Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

NCT ID: NCT03452527

Last Updated: 2021-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-04-25

Brief Summary

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The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.

Detailed Description

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Conditions

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Choroidal Neovascularization Wet Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICON-1 maintenance therapy

ICON-1 maintenance therapy after initial aflibercept treatment

Group Type EXPERIMENTAL

ICON-1

Intervention Type BIOLOGICAL

ICON-1 0.6 mg by intravitreal injection

aflibercept

Intervention Type BIOLOGICAL

aflibercept 2 mg by intravitreal injection

ICON-1 combination therapy

ICON-1 combination therapy with aflibercept treatment

Group Type EXPERIMENTAL

ICON-1

Intervention Type BIOLOGICAL

ICON-1 0.6 mg by intravitreal injection

aflibercept

Intervention Type BIOLOGICAL

aflibercept 2 mg by intravitreal injection

Interventions

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ICON-1

ICON-1 0.6 mg by intravitreal injection

Intervention Type BIOLOGICAL

aflibercept

aflibercept 2 mg by intravitreal injection

Intervention Type BIOLOGICAL

Other Intervention Names

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human Immuno-conjugate 1 Eylea®

Eligibility Criteria

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Inclusion Criteria

* Males or females of any race, ≥50 years of age
* Active primary CNV secondary to AMD in the study eye

Exclusion Criteria

* Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
* Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
* Vitrectomy in the study eye
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iconic Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriela Burian, MD

Role: STUDY_DIRECTOR

Iconic Therapeutics, Inc.

Locations

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Site 2

Beverly Hills, California, United States

Site Status

Site 8

Santa Ana, California, United States

Site Status

Site 7

Syracuse, New York, United States

Site Status

Site 3

Ashland, Oregon, United States

Site Status

Site 6

Philadelphia, Pennsylvania, United States

Site Status

Site 1

Austin, Texas, United States

Site Status

Site 4

McAllen, Texas, United States

Site Status

Site 5

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IT-004

Identifier Type: -

Identifier Source: org_study_id

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