Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
NCT ID: NCT02358889
Last Updated: 2020-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2015-02-28
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
hI-con1
Intravitreal injection of hI-con1 0.3 mg
Sham injection
No injection is given, a needleless syringe is used to mimic an injection.
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.
hI-con1
Intravitreal injection of hI-con1 0.3 mg
ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
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.
ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Sham injection
No injection is given, a needleless syringe is used to mimic an injection.
Interventions
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hI-con1
Intravitreal injection of hI-con1 0.3 mg
ranibizumab
Intravitreal injection of ranibizumab 0.5 mg
Sham injection
No injection is given, a needleless syringe is used to mimic an injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
ALL
No
Sponsors
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Iconic Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gabriela Burian, MD
Role: STUDY_DIRECTOR
Iconic Therapeutics, Inc.
Locations
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Phoenix, Arizona, United States
Phoenix, Arizona, United States
Arcadia, California, United States
Beverly Hills, California, United States
Campbell, California, United States
Glendale, California, United States
Laguna Hills, California, United States
Mountain View, California, United States
Palm Desert, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Fort Myers, Florida, United States
Panama City, Florida, United States
Sarasota, Florida, United States
Stuart, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Jackson, Michigan, United States
Royal Oak, Michigan, United States
West Bloomfield, Michigan, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Bloomfield, New Jersey, United States
Brooklyn, New York, United States
Hauppauge, New York, United States
Syracuse, New York, United States
Ashland, Oregon, United States
Portland, Oregon, United States
Huntingdon Valley, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Columbia, South Carolina, United States
Kingsport, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Silverdale, Washington, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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IT-002
Identifier Type: -
Identifier Source: org_study_id
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