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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 48 Study Locations

Sponsors and Collaborators

Iconic Therapeutics, Inc.

Investigators

Study Director:	Gabriela Burian, MD	Iconic Therapeutics, Inc.

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT02358889 History of Changes
Other Study ID Numbers:	IT-002
First Posted:	February 9, 2015
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