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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02358889
Recruitment Status : Completed
First Posted : February 9, 2015
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Iconic Therapeutics, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Age-related Macular Degeneration Biological: hI-con1 Biological: ranibizumab Other: Sham injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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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 Name: 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 Name: human Immuno-conjugate 1

Biological: ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Other Name: 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.
 Biological: ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Other Name: Lucentis®

Other: Sham injection
No injection is given, a needleless syringe is used to mimic an injection.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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 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)
Contacts and Locations
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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): NCT02358889


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85020
Phoenix, Arizona, United States, 85021
United States, 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
United States, Colorado
Golden, Colorado, United States, 80401
United States, 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
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Kentucky
Paducah, Kentucky, United States, 42001
United States, Maryland
Baltimore, Maryland, United States, 21209
United States, Massachusetts
Boston, Massachusetts, United States, 02111
United States, Michigan
Detroit, Michigan, United States, 48072
Jackson, Michigan, United States, 49202
Royal Oak, Michigan, United States, 48073
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Minneapolis, Minnesota, United States, 55435
United States, Nevada
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Bloomfield, New Jersey, United States, 07003
United States, New York
Brooklyn, New York, United States, 11223
Hauppauge, New York, United States, 11788
Syracuse, New York, United States, 13224
United States, Oregon
Ashland, Oregon, United States, 97520
Portland, Oregon, United States, 97210
United States, Pennsylvania
Huntingdon Valley, Pennsylvania, United States, 19006
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, 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
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Washington
Silverdale, Washington, United States, 98383
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
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Study Director: Gabriela Burian, MD Iconic Therapeutics, Inc.
More Information
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Responsible Party: Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02358889    
Other Study ID Numbers: IT-002
First Posted: February 9, 2015    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Ranibizumab
Immunoconjugates
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors