Clinical trial NCT02358889: Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Age-related Macular Degeneration
Lead sponsor: Iconic Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Change From Baseline in BCVA in the Study Eye at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in CST in the Study Eye at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Campbell
country: United States
state: California
city: Glendale
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Golden
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Paducah
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: West Bloomfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Las Vegas
country: United States
state: Nevada
city: Bloomfield
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Hauppauge
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Ashland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Huntingdon Valley
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Columbia
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Silverdale
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Iconic Therapeutics, Inc.
name: Gabriela Burian, MD
role: STUDY_DIRECTOR
References: