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



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/1/2019
Start Date:March 14, 2018
End Date:November 28, 2019

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A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

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.

Subjects will be randomised in a 1:1 ratio to receive either SB11 or Lucentis® (administered
via intravitreal (ITV) 0.5 mg every 4 weeks). Investigational Products (IP) (SB11 or
Lucentis®) will be administered up to Week 48, and the last assessment will be done at Week
52.

Inclusion Criteria:

1. Age ≥ 50 years

2. Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to
AMD in the study eye

3. BCVA of 20/40 to 20/200 in the study eye

4. Written informed consent form

Exclusion Criteria:

1. Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to
treat neovascular AMD in either eye

2. Presence of CNV in either eye due to other causes, such as ocular histoplasmosis,
trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or
pathologic myopia

3. Any concurrent macular abnormality other than AMD in the study eye
We found this trial at
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Poway, California 92064
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
Phone: 808-487-8928
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Abilene, Texas 79606
Phone: 325-690-4414
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Augusta, Georgia 30909
Phone: 706-650-0061
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Austin, Texas 78705
Phone: 512-451-0103
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Bloomfield, New Jersey 07003
Phone: 973-707-5632
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Brno, 62500
Phone: +420532233263
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Colorado Springs, Colorado
Phone: 713-473-9595
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Conroe, Texas 77030
Phone: 936-273-6625
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Fort Myers, Florida 33912
Phone: 239-938-1284
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Great Neck, New York 11021
Phone: 516-466-0390
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Hauppauge, New York 11788
Phone: 631-234-5666
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Houston, Texas 77030
Phone: 713-524-3434
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Indianapolis, Indiana 46290
Phone: 317-817-1414
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Indianapolis, IN
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Ladson, South Carolina 29456
Phone: 843-763-4466
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Middleburg Heights, Ohio 44130
Phone: 216-831-5700
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Rapid City, South Dakota 57701
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Rochester, New York 14620
Phone: 585-442-3411
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Rochester, NY
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Syracuse, New York 13224
Phone: 315-445-8166
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780 Route 37 West
Toms River, New Jersey 08755
Phone: 732-797-3984
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