A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Part of paid clinical trials in Poway, California.

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT03150589
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

Key Dates

First listed
May 12, 2017
Start date
Mar 14, 2018
Status verified
Apr 2021
Primary completion
May 24, 2019
Completion
Dec 9, 2019

Study Design

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

Arms

  • Experimental: SB11 (Proposed ranibizumab biosimilar)
  • Active Comparator: Lucentis (ranibizumab)

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline and Week 8 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Retina consultants San DiegoPowayCalifornia92064-
Retina Consultants of Southern ColoradoColorado SpringsColorado80909-
Retina ConsultantsFort MyersFlorida33912-
Southeast Retina CenterAugustaGeorgia30909-
Retina Consultants of Hawaii‘AieaHawaii96701-
Raj K. Maturi, MD, PCIndianapolisIndiana46280-
Retina Center of New Jersey, LLCBloomfieldNew Jersey07003-
NJ RetinaToms RiverNew Jersey08755-8063-
LIVRGreat NeckNew York11021-
Long Island Vitreoretinal ConsultantsHauppaugeNew York11788-
Retina Associates of Western NYRochesterNew York14620-
Retina Vitreous Surgeons fo Central NY, PCSyracuseNew York13224-
Retina Associates of ClevelandMiddleburg HeightsOhio44130-
Charleston Neuroscience InstituteLadsonSouth Carolina29414-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Retina Research Institute of TexasAbileneTexas79606-
Austin Restina AssociatesAustinTexas78705-
Retina consultants of HoustonConroeTexas77030-
Retina Consultants of HoustonHoustonTexas77030-

Find similar trials in Poway, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina consultants San Diego· Poway, CARetina Consultants of Southern Colorado· Colorado Springs, CORetina Consultants· Fort Myers, FLSoutheast Retina Center· Augusta, GARetina Consultants of Hawaii· ‘Aiea, HIRaj K. Maturi, MD, PC· Indianapolis, IN

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