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

Phase 2

Terminated

• Conditions: Choroidal Neovascularization; Wet Macular Degeneration
• Interventions: Biological: ICON-1; Biological: aflibercept

• Registration Number: NCT03452527
• Lead Sponsor: Iconic Therapeutics, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Study Start: 2018-03-26
• Primary Completion: 2019-04-25
• Study Completion: 2019-04-25
• Results First Submitted: 2020-09-01
• Status Verified: 2020-11
• Results First Submitted QC: 2021-02-19
• Results First Posted: 2021-03-15
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICON-1 maintenance therapy	aflibercept	ICON-1 maintenance therapy after initial aflibercept treatment
ICON-1 combination therapy	aflibercept	ICON-1 combination therapy with aflibercept treatment
ICON-1 combination therapy	ICON-1	ICON-1 combination therapy with aflibercept treatment
ICON-1 maintenance therapy	ICON-1	ICON-1 maintenance therapy after initial aflibercept treatment

Primary Outcome Measures

Name	Time	Method
Change in Choroidal Neovascularization (CNV) Over Time	Month 9	Mean change from baseline in CNV area in the study eye

Secondary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) Over Time	Month 9	Mean change from baseline in BCVA letter score in the study eye

Trial Locations

Locations (8)

Site 2; 🇺🇸 Beverly Hills, California, United States

Site 3; 🇺🇸 Ashland, Oregon, United States

Site 1; 🇺🇸 Austin, Texas, United States

Site 4; 🇺🇸 McAllen, Texas, United States

Site 8; 🇺🇸 Santa Ana, California, United States

Site 7; 🇺🇸 Syracuse, New York, United States

Site 6; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 5; 🇺🇸 San Antonio, Texas, United States