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

March 21, 2021 updated by: Iconic Therapeutics, Inc.

A Phase 2 Randomized, Open-Label, Multicenter Study Evaluating Administration of Repeated Intravitreal Doses of ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Site 2
      • Santa Ana, California, United States, 92705
        • Site 8
    • New York
      • Syracuse, New York, United States, 13224
        • Site 7
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Site 3
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Site 6
    • Texas
      • Austin, Texas, United States, 78705
        • Site 1
      • McAllen, Texas, United States, 78503
        • Site 4
      • San Antonio, Texas, United States, 78240
        • Site 5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICON-1 maintenance therapy
ICON-1 maintenance therapy after initial aflibercept treatment
Biological: ICON-1
ICON-1 0.6 mg by intravitreal injection
Other Names:
  • human Immuno-conjugate 1
Biological: aflibercept
aflibercept 2 mg by intravitreal injection
Other Names:
  • Eylea®
Experimental: ICON-1 combination therapy
ICON-1 combination therapy with aflibercept treatment
Biological: ICON-1
ICON-1 0.6 mg by intravitreal injection
Other Names:
  • human Immuno-conjugate 1
Biological: aflibercept
aflibercept 2 mg by intravitreal injection
Other Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Choroidal Neovascularization (CNV) Over Time
Time Frame: Month 9
Mean change from baseline in CNV area in the study eye
Month 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best Corrected Visual Acuity (BCVA) Over Time
Time Frame: Month 9
Mean change from baseline in BCVA letter score in the study eye
Month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iconic Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2018

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

April 25, 2019

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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