Clinical trial NCT02659098: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Visual Acuity
Geographic Atrophy
Macular Degeneration
Keywords: Best Corrected Visual Acuity
Geographic Atrophy
Macular Degeneration
CNTO 2476
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Treated Eye
timeFrame: Baseline and Month 1
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Treated Eye
timeFrame: Baseline and Month 2
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Treated Eye
timeFrame: Baseline and Month 3
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Treated Eye
timeFrame: Baseline and Month 6
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Treated Eye
timeFrame: Baseline and Month 12
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Treated Eye
timeFrame: Baseline and Month 18
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 24- Treated Eye
timeFrame: Baseline and Month 24
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 30- Treated Eye
timeFrame: Baseline and Month 30
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 36- Treated Eye
timeFrame: Baseline and Month 36
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Total Letters Score at Month 1- Fellow Eye
timeFrame: Baseline and Month 1
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 2- Fellow Eye
timeFrame: Baseline and Month 2
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 3- Fellow Eye
timeFrame: Baseline and Month 3
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 6- Fellow Eye
timeFrame: Baseline and Month 6
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 12- Fellow Eye
timeFrame: Baseline and Month 12
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 18- Fellow Eye
timeFrame: Baseline and Month 18
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 24- Fellow Eye
timeFrame: Baseline and Month 24
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 30- Fellow Eye
timeFrame: Baseline and Month 30
measure: Change From Baseline in Best Corrected Visual Acuity Total Letters Score at Month 36- Fellow Eye
timeFrame: Baseline and Month 36
Secondary outcomes:
measure: Percentage of Participants Losing Greater Than or Equal to (>=) 15 Best Corrected Visual Acuity Letters: Treated Eye
timeFrame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
measure: Percentage of Participants Losing >=15 Best Corrected Visual Acuity Letters: Fellow Eye
timeFrame: Months 1, 2 , 3, 6, 12, 18, 24, 30 and 36
measure: Change From Baseline in Best Corrected Visual Acuity Letters at Months 6 and 12: Treated Eye
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Best Corrected Visual Acuity at Months 6 and 12: Fellow Eye
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Growth Rate of Geographic Atrophy (GA) Lesion Area at Months 6 and 12: Treated Eye
timeFrame: Baseline, Months 6 and 12
measure: Change From Baseline in Growth Rate of Geographic Atrophy Lesion Area at Months 6 and 12: Fellow Eye
timeFrame: Baseline, Months 6 and 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Months 36
measure: Number of Participants With Ocular Treatment-emergent Adverse Events
timeFrame: Up to Months 36
Other outcomes:
Locations:
city: Arcadia
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: