Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02358889
First received: February 4, 2015
Last updated: October 11, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Choroidal Neovascularization
Age-related Macular Degeneration
Biological: hI-con1
Biological: ranibizumab
Other: Sham injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Iconic Therapeutics, Inc.:

Primary Outcome Measures:
  • 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

  • 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:
  • 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

  • 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


Enrollment: 88
Study Start Date: February 2015
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02358889

  Show 48 Study Locations
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
Study Director: Gabriela Burian, MD Iconic Therapeutics, Inc.
  More Information

Responsible Party: Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02358889     History of Changes
Other Study ID Numbers: IT-002
Study First Received: February 4, 2015
Last Updated: October 11, 2016

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

ClinicalTrials.gov processed this record on April 28, 2017