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

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ClinicalTrials.gov Identifier: NCT03452527
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Wet Macular Degeneration Biological: ICON-1 Biological: aflibercept Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


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 Name: human Immuno-conjugate 1

Biological: aflibercept
aflibercept 2 mg by intravitreal injection
Other Name: 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 Name: human Immuno-conjugate 1

Biological: aflibercept
aflibercept 2 mg by intravitreal injection
Other Name: Eylea®




Primary Outcome Measures :
  1. Change in choroidal neovascularization (CNV) over time [ Time Frame: Month 9 ]
    Mean change from baseline in CNV area in the study eye


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452527


Locations
United States, California
Site 2
Beverly Hills, California, United States, 90211
Site 8
Santa Ana, California, United States, 92705
United States, New York
Site 7
Syracuse, New York, United States, 13224
United States, Oregon
Site 3
Ashland, Oregon, United States, 97520
United States, Pennsylvania
Site 6
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Site 1
Austin, Texas, United States, 78705
Site 4
McAllen, Texas, United States, 78503
Site 5
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
Study Director: Gabriela Burian, MD Iconic Therapeutics, Inc.

Responsible Party: Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03452527     History of Changes
Other Study ID Numbers: IT-004
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs