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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

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
    • 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

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
Intervention / Treatment
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

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

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

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

February 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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