A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Opthea Limited
Study ID
NCT03345082
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • OPT-302 — BIOLOGICAL
    Intravitreal injection
  • ranibizumab — BIOLOGICAL
    Intravitreal injection
  • sham intravitreal injection — OTHER
    Sham (mock) intravitreal injection

Study Details

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Key Dates

First listed
Nov 17, 2017
Start date
Nov 6, 2017
Status verified
Jan 2020
Primary completion
May 14, 2019
Completion
May 14, 2019

Study Design

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

Arms

  • Experimental: 0.5 mg ranibizumab with 2.0 mg OPT-302
    0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
  • Experimental: 0.5 mg ranibizumab with 0.5 mg OPT-302
    0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
  • Sham Comparator: 0.5 mg ranibizumab with sham
    0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham

Primary Outcome Measure

Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) [ Time Frame: Baseline to Week 24 ]

Locations (55)

FacilityCityStateZIPSite coordinators
Opthea Investigational SitePhoenixArizona85014-
Opthea Investigational SitePhoenixArizona85020-
Opthea Investigational SiteBeverly HillsCalifornia90211-
Opthea Investigational SiteEncinoCalifornia91436-
Opthea Investigational SitePalm DesertCalifornia92260-
Opthea Investigational SiteRedlandsCalifornia92374-
Opthea Investigational SiteSacramentoCalifornia95841-
Opthea Study SiteSacramentoCalifornia95819-
Opthea Investigational SiteSan DiegoCalifornia94143-
Opthea Investigational SiteSanta AnaCalifornia92705-
Opthea Investigational SiteSanta BarbaraCalifornia93103-
Opthea Investigational SiteSanta MariaCalifornia93454-
Opthea Investigational SiteColorado SpringsColorado80909-
Opthea Investigational SiteGoldenColorado80401-
Opthea Investigational SiteBoynton BeachFlorida33426-
Opthea Investigational SiteFort MyersFlorida33907-
Opthea Investigational SiteFort MyersFlorida33912-
Opthea Investigational SiteMelbourneFlorida32901-
Opthea Investigational SitePensacolaFlorida32503-
Opthea Investigational SiteSt. PetersburgFlorida33703-
Opthea Investigational SiteTallahasseeFlorida32308-
Opthea Investigational SiteWinter HavenFlorida33880-
Opthea Investigational SiteAugustaGeorgia30909-
Opthea Investigational SiteShawnee MissionKansas66204-
Opthea Investigational SiteWichitaKansas67214-
Opthea Investigational SitePaducahKentucky42001-
Opthea Investigational SiteBaltimoreMaryland21204-
Opthea Investigational SiteGrand RapidsMichigan49546-
Opthea Investigational SiteLas VegasNevada89144-
Opthea Investigational SiteRenoNevada89502-
Opthea Investigational SiteEdisonNew Jersey08820-
Opthea Investigational SiteTeaneckNew Jersey07666-
Opthea Investigational SiteAlbuquerqueNew Mexico87109-
Opthea Investigational SiteLynbrookNew York11563-
Opthea Investigational SiteRochesterNew York14620-
Opthea Investigational SiteSyracuseNew York13224-
Opthea Investigational SiteAshevilleNorth Carolina28803-
Opthea Investigational SiteCharlotteNorth Carolina28210-
Opthea Investigational SiteClevelandOhio44195-
Opthea Investigational SiteColumbusOhio43212-
Opthea Investigational SitePortlandOregon97239-
Opthea Investigational SiteCamp HillPennsylvania17011-
Opthea Investigational SiteKingstonPennsylvania18704-
Opthea Investigational SitePhiladelphiaPennsylvania19107-
Opthea Investigational SiteLadsonSouth Carolina29456-
Opthea Investigational SiteWest ColumbiaSouth Carolina29169-
Opthea Investigational SiteAbileneTexas79606-
Opthea Investigational SiteAustinTexas78705-
Opthea Investigational SiteHoustonTexas77030-
Opthea Investigational SiteSan AntonioTexas78240-
Opthea Investigational SiteThe WoodlandsTexas77384-
Opthea Investigational SiteWillow ParkTexas76087-
Opthea Investigational SiteFairfaxVirginia22031-
Opthea Investigational SiteVirginia BeachVirginia23462-
Opthea Investigational SiteSilverdaleWashington98383-

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