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

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ClinicalTrials.gov Identifier: NCT02358889
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : December 2, 2017
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 ]
    Mean change in BCVA letter score from baseline to the Month 3 visit

  2. Change from baseline in central retinal subfield thickness (CST) in the study eye at Month 3 [ Time Frame: Baseline and Month 3 ]
    Mean change in CST from baseline to the Month 3 visit


Secondary Outcome Measures :
  1. Change from baseline in BCVA in the study eye at Month 6 [ Time Frame: Baseline and Month 6 ]
    Mean change in BCVA letter score from baseline to the Month 6 visit

  2. Change from baseline in CST in the study eye at Month 6 [ Time Frame: Baseline and Month 6 ]
    Mean change in CST from baseline to the Month 6 visit


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 CNV secondary to AMD in the study eye
  • 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


  Show 48 Study Locations
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
Study Director: Gabriela Burian, MD Iconic Therapeutics, Inc.
More Information
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Responsible Party: Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02358889     History of Changes
Other Study ID Numbers: IT-002
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Ranibizumab
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents