Choroidal NeovascularizationPhase 2DECONCT03452527

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

A Phase 2 study testing ICON-1 and aflibercept in people with Choroidal Neovascularization and Wet Macular Degeneration, run by Iconic Therapeutics, Inc. at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Choroidal Neovascularization, Wet Macular Degeneration
What is being tested?: ICON-1 and aflibercept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 8 sitesUnited States
Study dates: 26 Mar 2018to 25 Apr 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females of any race, ≥50 years of age
Active primary CNV secondary to AMD in the study eye

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

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

Conditions: Choroidal Neovascularization, Wet Macular Degeneration
Being tested: ICON-1, aflibercept
Medical subject headings: Choroidal Neovascularization, Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICON-1Biological
Also called human Immuno-conjugate 1
ICON-1 0.6 mg by intravitreal injection
afliberceptBiological
Also called Eylea®
aflibercept 2 mg by intravitreal injection

Study groups in NCT03452527
Study group	Role	What they receive
ICON-1 maintenance therapy	Experimental	ICON-1 maintenance therapy after initial aflibercept treatment Receives: Biological: ICON-1; Biological: aflibercept
ICON-1 combination therapy	Experimental	ICON-1 combination therapy with aflibercept treatment Receives: Biological: ICON-1; Biological: aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201825 Apr 2019

First posted2 Mar 2018
Study start26 Mar 2018
Primary completion25 Apr 2019
Study completion25 Apr 2019

Why it stopped: Business Reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03452527
Sponsor's protocol ID: IT-004
Acronym: DECO
Status last verified: Nov 2020
First submitted: 26 Feb 2018
Last updated: 13 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

All Choroidal Neovascularization trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03452527
Acronym / sponsor ID: DECO / IT-004
Conditions: Choroidal Neovascularization, Wet Macular Degeneration
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Reasons
Enrolment: 15 participants (actual)
Lead sponsor: Iconic Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 26 Mar 2018 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 2 Mar 2018 (actual)
Results: Posted 15 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ICON-1 maintenance therapy	Experimental	Biological: ICON-1, Biological: afliberceptICON-1 maintenance therapy after initial aflibercept treatment
ICON-1 combination therapy	Experimental	Biological: ICON-1, Biological: afliberceptICON-1 combination therapy with aflibercept treatment

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Males or females of any race, ≥50 years of age
Active primary CNV secondary to AMD in the study eye

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICON-1Also: human Immuno-conjugate 1ICON-1 0.6 mg by intravitreal injection	Biological	ICON-1 combination therapy, ICON-1 maintenance therapy
afliberceptAlso: Eylea®aflibercept 2 mg by intravitreal injection	Biological	ICON-1 combination therapy, ICON-1 maintenance therapy

Primary outcome

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

1 secondary outcome

Change in Best Corrected Visual Acuity (BCVA) Over Time
Time frame: Month 9

Results and safety

Results posted to the registry on 15 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ICON-1 Maintenance Therapy	7	4
ICON-1 Combination Therapy	8	4

Primary outcome: Change in Choroidal Neovascularization (CNV) Over Time

Time frame: Month 9. Number. Unit: participants

Measure	ICON-1 Maintenance Therapy n = 5	ICON-1 Combination Therapy n = 8
CNV Size-Smaller	2	5
CNV Size-No Change	2	2
CNV Size- Larger	0	1
CNV Size-Cannot Grade	1	0

Population analysed: 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.

1 secondary outcome is reported in the full results.

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ICON-1 Maintenance Therapy	2 of 7 (28.6%)	6 of 7 (85.7%)	0 of 7
ICON-1 Combination Therapy	1 of 8 (12.5%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Choroidal Neovascularization

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gabriela Burian, MD study director

Iconic Therapeutics, Inc.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICON-1 and aflibercept in people with Choroidal Neovascularization and Wet Macular Degeneration, run by Iconic Therapeutics, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Choroidal Neovascularization (CNV) Over Time (time frame: Month 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03452527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.