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

Phase 2TerminatedNCT03452527

Iconic Therapeutics, Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Choroidal Neovascularization Wet Macular Degeneration

Interventions

ICON-1BIOLOGICAL

ICON-1 0.6 mg by intravitreal injection

afliberceptBIOLOGICAL

aflibercept 2 mg by intravitreal injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (8)

Site 2

Beverly Hills, California, United States

Site 8

Santa Ana, California, United States

Site 7

Syracuse, New York, United States

Site 3

Ashland, Oregon, United States

Outcomes

Primary Outcomes

Change in Choroidal Neovascularization (CNV) Over Time

Mean change from baseline in CNV area in the study eye

Time frame: Month 9

Secondary Outcomes

Change in Best Corrected Visual Acuity (BCVA) Over Time

Mean change from baseline in BCVA letter score in the study eye

Time frame: Month 9

Data from ClinicalTrials.gov

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