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

• Sponsor: Iconic Therapeutics, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03452527
• Collaborator: (none)
• Enrollment: 15
• Locations: 8
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 26, 2018
• Actual Primary Completion Date: Apr 25, 2019
• Actual Study Completion Date: Apr 25, 2019

Arms and Interventions

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®

Outcome Measures

Primary Outcome Measures

1. Change in Choroidal Neovascularization (CNV) Over Time [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 [Month 9]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Iconic Therapeutics, Inc.

Investigators

• Study Director: Gabriela Burian, MD, Iconic Therapeutics, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 19, 2018

More Information

Publications

None provided.

• Responsible Party: Iconic Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT03452527
• Other Study ID Numbers: IT-004
• First Posted: Mar 2, 2018
• Last Update Posted: Apr 13, 2021
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration; Neovascularization, Pathologic; Aflibercept; Immunoconjugates

Study Results

Participant Flow

Arm/Group Title	ICON-1 Maintenance Therapy	ICON-1 Combination Therapy
Arm/Group Description	ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection	ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection
Period Title: Overall Study
STARTED	7	8
COMPLETED	4	4
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	ICON-1 Maintenance Therapy	ICON-1 Combination Therapy	Total
Arm/Group Description	ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection	ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection	Total of all reporting groups
Overall Participants	7	8	15
Age, Customized (Count of Participants)
50 to <65 Years	0 0%	1 12.5%	1 6.7%
65 to<75 Years	1 14.3%	2 25%	3 20%
75 to <85	3 42.9%	3 37.5%	6 40%
85 Years or older	3 42.9%	2 25%	5 33.3%
Sex: Female, Male (Count of Participants)
Female	5 71.4%	4 50%	9 60%
Male	2 28.6%	4 50%	6 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 25%	2 13.3%
Not Hispanic or Latino	7 100%	6 75%	13 86.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	7 100%	8 100%	15 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	8 100%	15 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The change in choroidal neovascularization by OCT-A, reported as assessed by the investigators. The changes did not correlate with the change in choroidal neovascularization by FA and therefore further analysis was not performed.

Arm/Group Title	ICON-1 Maintenance Therapy	ICON-1 Combination Therapy
Arm/Group Description	ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection	ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection
Measure Participants	5	8
CNV Size-Smaller	2 28.6%	5 62.5%
CNV Size-No Change	2 28.6%	2 25%
CNV Size- Larger	0 0%	1 12.5%
CNV Size-Cannot Grade	1 14.3%	0 0%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Due to the small sample size and early termination of the study conclusions can not be accurately made from the available data.

Arm/Group Title	ICON-1 Maintenance Therapy	ICON-1 Combination Therapy
Arm/Group Description	ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection	ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection
Measure Participants	6	8
Mean (Full Range) [Letters]	1	0

Adverse Events

Time Frame	Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.
Arm/Group Title	ICON-1 Maintenance Therapy		ICON-1 Combination Therapy
Arm/Group Description	ICON-1 maintenance therapy after initial aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection		ICON-1 combination therapy with aflibercept treatment ICON-1: ICON-1 0.6 mg by intravitreal injection aflibercept: aflibercept 2 mg by intravitreal injection
All Cause Mortality
	ICON-1 Maintenance Therapy		ICON-1 Combination Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/8 (0%)
Serious Adverse Events
	ICON-1 Maintenance Therapy		ICON-1 Combination Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		1/8 (12.5%)
Infections and infestations
Sepsis	1/7 (14.3%)	1	0/8 (0%)	0
Urosepsis	0/7 (0%)	0	1/8 (12.5%)	1
Nervous system disorders
Metabolic Encephalopathy	0/7 (0%)	0	1/8 (12.5%)	1
Vascular disorders
Transient Ischemic Attach (TIA)	1/7 (14.3%)	1	0/8 (0%)	0
Other (Not Including Serious) Adverse Events
	ICON-1 Maintenance Therapy		ICON-1 Combination Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/7 (85.7%)		8/8 (100%)
Eye disorders
Macular Fibrosis	1/7 (14.3%)	1	1/8 (12.5%)	1
Photopsia	1/7 (14.3%)	1	1/8 (12.5%)	1
Retinal Haemorrhage	1/7 (14.3%)	1	1/8 (12.5%)	1
Subretinal Fluid	0/7 (0%)	0	2/8 (25%)	2
Choroidal Neovascularization	0/7 (0%)	0	1/8 (12.5%)	1
Conjunctival Haemorrhage	0/7 (0%)	0	1/8 (12.5%)	1
Detachment of Retinal Pigment Epithelium	0/7 (0%)	0	1/8 (12.5%)	1
Dry Age Related Macular Degeneration	0/7 (0%)	0	1/8 (12.5%)	1
Dry eye	1/7 (14.3%)	1	0/8 (0%)	0
Eyelids Pruritus	0/7 (0%)	0	1/8 (12.5%)	1
Lacrimation Increased	1/7 (14.3%)	1	0/8 (0%)	0
Macular Oedema	0/7 (0%)	0	1/8 (12.5%)	1
Metamorphopsia	1/7 (14.3%)	1	0/8 (0%)	0
Optic Ischaemic Neuropathy	0/7 (0%)	0	1/8 (12.5%)	1
Retinal Depigmentation	0/7 (0%)	0	1/8 (12.5%)	1
Retinal Pigment Epithelial Tear	1/7 (14.3%)	1	0/8 (0%)	0
Visual Acuity Reduced	1/7 (14.3%)	1	0/8 (0%)	0
Visual lmpairement	1/7 (14.3%)	1	0/8 (0%)	0
Vitreous Detachment	0/7 (0%)	0	1/8 (12.5%)	1
Vitreous Haemorrhage	1/7 (14.3%)	1	0/8 (0%)	0
Intraocular Pressure Increased	1/7 (14.3%)	1	2/8 (25%)	2
Vomiting	0/7 (0%)	0	1/8 (12.5%)	1
Gastrointestinal disorders
Gastritis	1/7 (14.3%)	1	0/8 (0%)	0
Gastrooesophageal Reflux Disease	1/7 (14.3%)	1	0/8 (0%)	0
General disorders
Asthenia	0/7 (0%)	0	1/8 (12.5%)	1
Immune system disorders
Drug Hypersensitivity	1/7 (14.3%)	1	0/8 (0%)	0
Hypersensitivity	0/7 (0%)	0	1/8 (12.5%)	1
Infections and infestations
Nasopharyngitis	0/7 (0%)	0	2/8 (25%)	2
Urinary Tract Infection	0/7 (0%)	0	2/8 (25%)	2
Cystitis	1/7 (14.3%)	1	0/8 (0%)	0
Genital Herpes	0/7 (0%)	0	1/8 (12.5%)	1
Wound Infection	1/7 (14.3%)	1	0/8 (0%)	0
Injury, poisoning and procedural complications
Fall	0/7 (0%)	0	1/8 (12.5%)	1
Laceration	1/7 (14.3%)	1	0/8 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.