OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Opthea Limited
Study ID
NCT04757636
Phase
PHASE3
Status
Terminated

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • 2.0 mg OPT-302 — BIOLOGICAL
    intravitreal injection
  • 2.0 aflibercept — BIOLOGICAL
    intravitreal injection
  • Sham — PROCEDURE
    intravitreal injection

Study Details

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Key Dates

Start date
Mar 12, 2021
Status verified
Jun 2025
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

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

Arms

  • Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
    2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
  • Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
    2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
  • Sham Comparator: 2.0 mg aflibercept with sham
    2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.

Primary Outcome Measure

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters [ Time Frame: Baseline to Week 52 ]

Locations (60)

FacilityCityStateZIPSite coordinators
COAST Investigational SitePhoenixArizona85053-
COAST Investigational SiteArcadiaCalifornia91006-
COAST Investigational SiteHuntington BeachCalifornia92647-
COAST Investigational SiteRedlandsCalifornia92374-
COAST Investigational SiteSacramentoCalifornia95841-
COAST Investigational SiteDanburyConnecticut06810-
COAST Investigational SiteAltamonte SpringsFlorida32750-
COAST Investigational SiteBoynton BeachFlorida33426-
COAST Investigational SiteCoral SpringsFlorida33067-
COAST Investigational SiteMelbourneFlorida32901-
COAST Investigational SiteOrlandoFlorida32806-
COAST Investigational SitePlantationFlorida33324-
COAST Investigational SiteSarasotaFlorida34239-
COAST Investigational SiteSt. PetersburgFlorida33711-
COAST Investigational SiteStuartFlorida34994-
COAST Investigational SiteWinter HavenFlorida33880-
COAST Investigational SiteMariettaGeorgia30060-
COAST Investigational Site‘AieaHawaii96701-
COAST Investigational SiteChicagoIllinois60611-
COAST Investigational SiteSpringfieldIllinois62704-
COAST Investigational SiteUrbanaIllinois61822-
COAST Investigational SiteNew AlbanyIndiana47150-
COAST Investigational SiteLenexaKansas66215-
COAST Investigational SitePrairie VillageKansas66208-
COAST Investigational SiteWest MonroeLouisiana71291-
COAST Investigational SiteHagerstownMaryland21740-
COAST Investigational SiteOwings MillsMaryland21117-
COAST Investigational SiteBostonMassachusetts02114-
COAST Investigational SiteWorcesterMassachusetts01605-
COAST Investigational SiteJacksonMississippi39202-
COAST Investigational SiteIndependenceMissouri64055-
COAST Investigational SiteSt LouisMissouri63128-
COAST Investigational SiteEdisonNew Jersey08820-
COAST Investigational SiteAlbuquerqueNew Mexico87109-
COAST Investigational siteShirleyNew York11967-
COAST Investigational SiteAshevilleNorth Carolina28803-
COAST Investigational SiteWilmingtonNorth Carolina28401-
COAST Investigational SiteWinston-SalemNorth Carolina27157-
COAST Investigational SiteCincinnatiOhio45202-
COAST Investigational SiteDaytonOhio45459-
COAST Investigational SiteOklahoma CityOklahoma73102-
COAST Investigational SiteSpringfieldOregon97477-
COAST Investigational SiteKingstonPennsylvania18704-
COAST Investigational SitePhiladelphiaPennsylvania19107-
COAST Investigational SiteGreenvilleSouth Carolina29605-
COAST Investigational SiteWest ColumbiaSouth Carolina29169-
COAST Investigational SiteRapid CitySouth Dakota57701-
COAST Investigational SiteGermantownTennessee38138-
COAST Investigational SiteKnoxvilleTennessee37922-
COAST Investigational SiteAbileneTexas79606-
COAST Investigational SiteAustinTexas78705-
COAST Investigational SiteBurlesonTexas76028-
COAST Investigational SiteConroeTexas77384-
COAST Investigational SiteDallasTexas75243-
COAST Investigational SitePlanoTexas75075-
COAST Investigational SiteRound RockTexas78681-
COAST Investigational SiteFairfaxVirginia22031-
COAST Investigational SiteBellevueWashington98004-
COAST Investigational SiteSpokaneWashington99204-
COAST Investigational SiteMorgantownWest Virginia26505-

Find similar trials in Phoenix, AZ

By research site
COAST Investigational Site· Phoenix, AZCOAST Investigational Site· Arcadia, CACOAST Investigational Site· Huntington Beach, CACOAST Investigational Site· Redlands, CACOAST Investigational Site· Sacramento, CACOAST Investigational Site· Danbury, CT

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