A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - 90
Updated:2/13/2019
Start Date:March 21, 2016
End Date:June 20, 2019

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A Phase 2b, Multicenter, Double-masked, Randomized Study Evaluating the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age Related Macular Degeneration

The purpose of this study is to evaluate the safety and performance profile of the
suprachoroidal surgical approach and the Delivery System.

This is a multicenter (when more than one hospital or medical school team work on a medical
research study) study which includes an initial unmasked safety phase. The duration of
participation in the study for each participant is approximately 3 years. Efficacy will be
evaluated at 6 months, 12 months and annually thereafter. Participants' safety will be
monitored throughout the study.

Inclusion Criteria:

- Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration
(AMD) confirmed within 45 days prior to initial randomization verified by the central
reading center

- Study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early
Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution
(logMAR) value 0.6-1.6]. The treatment eye will be that with the worse BCVA at
Screening. If BCVA is clinically equivalent, the eye with the larger GA determines the
study eye

- Participant is a suitable candidate for ophthalmologic surgery, is willing and able to
comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests
and other study procedures. Participant has met criteria of the surgery center
anti-coagulation protocol, if applicable

- Each participant must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study

Exclusion Criteria:

- Participant has a history of neovascular ("wet") AMD in the treatment eye, including
evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal
neovascularization or fluid. In cases where imaging is inconclusive, review of the
case with the study site, considering history and imaging will determine eligibility.
History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular
endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks
prior to Screening

- Geographic atrophy secondary to any causes other than AMD in either eye

- A diagnosis of glaucoma with an intraocular pressure (IOP) greater than or equal to
(>=) 25 millimeter of mercury (mmHg) while being treated with an ocular hypotensive
drug. Treatment should be no more than 1 drug preparation/combination, which can
contain 1 or 2 ocular hypotensive active ingredients; participants receiving more than
2 ocular hypotensive active ingredients are excluded

- Nuclear sclerotic cataract, cortical spoking, posterior subcapsular cataract above
Grade 2 per Age Related Eye Disease Study (AREDS) scale or any other ophthalmologic
condition that reduces the clarity of the media that, in the opinion of the
investigator or reading center, interferes with ophthalmologic examination (example,
corneal abnormalities, inadequate pupillary dilation), surgery or imaging in the study
eye

- Myopia greater than minus (>-) 8 diopters and participants with greater than (>) 4
diopters of astigmatism, and greater than plus (>+) 10 diopters of hyperopia
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