Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (EMERGE)

September 23, 2020 updated by: Iconic Therapeutics, Inc.

A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Arizona
      • Phoenix, Arizona, United States, 85020
      • Phoenix, Arizona, United States, 85021
    • California
      • Arcadia, California, United States, 91007
      • Beverly Hills, California, United States, 90211
      • Campbell, California, United States, 95008
      • Glendale, California, United States, 91203
      • Laguna Hills, California, United States, 92653
      • Mountain View, California, United States, 94040
      • Palm Desert, California, United States, 92260
      • Palo Alto, California, United States, 94303
      • San Francisco, California, United States, 94109
      • Santa Ana, California, United States, 92705
    • Colorado
      • Golden, Colorado, United States, 80401
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Fort Myers, Florida, United States, 33907
      • Panama City, Florida, United States, 32405
      • Sarasota, Florida, United States, 34233
      • Stuart, Florida, United States, 34994
      • Winter Haven, Florida, United States, 33907
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Kentucky
      • Paducah, Kentucky, United States, 42001
    • Maryland
      • Baltimore, Maryland, United States, 21209
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Detroit, Michigan, United States, 48072
      • Jackson, Michigan, United States, 49202
      • Royal Oak, Michigan, United States, 48073
      • West Bloomfield, Michigan, United States, 48322
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
    • Nevada
      • Las Vegas, Nevada, United States, 89144
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
    • New York
      • Brooklyn, New York, United States, 11223
      • Hauppauge, New York, United States, 11788
      • Syracuse, New York, United States, 13224
    • Oregon
      • Ashland, Oregon, United States, 97520
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Huntingdon Valley, Pennsylvania, United States, 19006
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Abilene, Texas, United States, 79606
      • Austin, Texas, United States, 78705
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
      • The Woodlands, Texas, United States, 77384
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Washington
      • Silverdale, Washington, United States, 98383
    • Wisconsin
      • Madison, Wisconsin, United States, 53705

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 at least 50 years of age
  • Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
  • Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye

Exclusion Criteria:

  • Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
  • 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
  • Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: hI-con1
Patients will receive monthly intravitreal hI-con1 as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Biological: hI-con1
Intravitreal injection of hI-con1 0.3 mg
Other Names:
  • human Immuno-conjugate 1
Other: Sham injection
No injection is given, a needleless syringe is used to mimic an injection.
Experimental: hI-con1 + ranibizumab
Patients will receive monthly intravitreal hI-con1 in combination with intravitreal ranibizumab for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Biological: hI-con1
Intravitreal injection of hI-con1 0.3 mg
Other Names:
  • human Immuno-conjugate 1
Biological: ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Other Names:
  • Lucentis®
Active Comparator: ranibizumab
Patients will receive monthly intravitreal ranibizumab as monotherapy (plus sham injection) for the first 2 months followed by monthly treatment for 3 months, as needed, according to protocol criteria.
Other: Sham injection
No injection is given, a needleless syringe is used to mimic an injection.
Biological: ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
Time Frame: Baseline and Month 3
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Baseline and Month 3
Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
Time Frame: Baseline and Month 3
Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.
Baseline and Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA in the Study Eye at Month 6
Time Frame: Baseline and Month 6
Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.
Baseline and Month 6
Change From Baseline in CST in the Study Eye at Month 6
Time Frame: Baseline and Month 6
Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.
Baseline and Month 6

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IT-002

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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