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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Iconic Therapeutics, Inc.
Study ID
NCT02358889
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hI-con1 — BIOLOGICAL
    Intravitreal injection of hI-con1 0.3 mg
  • ranibizumab — BIOLOGICAL
    Intravitreal injection of ranibizumab 0.5 mg
  • Sham injection — OTHER
    No injection is given, a needleless syringe is used to mimic an injection.

Study Details

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).

Key Dates

First listed
Feb 9, 2015
Start date
Feb 28, 2015
Status verified
Sep 2020
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3 [ Time Frame: Baseline and Month 3 ]

Locations (48)

FacilityCityStateZIPSite coordinators
-PhoenixArizona85020-
-PhoenixArizona85021-
-ArcadiaCalifornia91007-
-Beverly HillsCalifornia90211-
-CampbellCalifornia95008-
-GlendaleCalifornia91203-
-Laguna HillsCalifornia92653-
-Mountain ViewCalifornia94040-
-Palm DesertCalifornia92260-
-Palo AltoCalifornia94303-
-San FranciscoCalifornia94109-
-Santa AnaCalifornia92705-
-GoldenColorado80401-
-Boynton BeachFlorida33426-
-Fort MyersFlorida33907-
-Panama CityFlorida32405-
-SarasotaFlorida34233-
-StuartFlorida34994-
-Winter HavenFlorida33907-
-AugustaGeorgia30909-
-PaducahKentucky42001-
-BaltimoreMaryland21209-
-BostonMassachusetts02111-
-DetroitMichigan48072-
-JacksonMichigan49202-
-Royal OakMichigan48073-
-West BloomfieldMichigan48322-
-MinneapolisMinnesota55435-
-Las VegasNevada89144-
-BloomfieldNew Jersey07003-
-BrooklynNew York11223-
-HauppaugeNew York11788-
-SyracuseNew York13224-
-AshlandOregon97520-
-PortlandOregon97210-
-Huntingdon ValleyPennsylvania19006-
-PhiladelphiaPennsylvania19107-
-West ColumbiaSouth Carolina29169-
-KingsportTennessee37660-
-AbileneTexas79606-
-AustinTexas78705-
-HoustonTexas77030-
-McAllenTexas78503-
-San AntonioTexas78240-
-The WoodlandsTexas77384-
-Salt Lake CityUtah84107-
-SilverdaleWashington98383-
-MadisonWisconsin53705-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina

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