A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
Phase 1/2a, Multicenter, Randomized, Dose Escalation, Fellow-Eye Controlled, Study Evaluating the Safety and Clinical Response of a Single, Subretinal Administration of Human Umbilical Tissue-Derived Cells (CNTO 2476) in Subjects With Visual Acuity Impairment Associated With Geographic Atrophy Secondary to Age-related Macular Degeneration
2 other identifiers
interventional
39
1 country
2
Brief Summary
The main purpose of this study to evaluate the safety and tolerability of CNTO 2476 administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in patients with visual acuity (acuteness or clearness of vision) impairment associated with the geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina) manifestation of age-related macular degeneration (AMD: medical condition which usually affects older adults and results in a loss of vision in the center of the visual field \[the macula\] because of damage to the retina).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2010
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2010
CompletedStudy Start
First participant enrolled
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
October 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedAugust 8, 2017
August 1, 2017
4.4 years
October 21, 2010
August 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of eyes with serious ocular adverse events occurring over the first 12 months of the study
This number will be summarized descriptively for treated and fellow eyes within each dose level included in Phase 1 and Phase 2a portions of the study
12 months
Secondary Outcomes (5)
Change from baseline in antibody peak values
Baseline (Screening), up to 60 months
Yearly rate of increase from baseline in area of Geographic Atrophy (GA)
Baseline (Screening), up to 60 months
Changes from baseline in visual function
Baseline (Screening), up to 60 months
Change from baseline in Visual Functioning Questionnaire (VFQ)-25
Baseline (Screening), up to 60 months
Incidence of adverse events
up to 60 months
Study Arms (8)
Cohort A
EXPERIMENTALPhase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)
Cohort B
EXPERIMENTALPhase 1: 3 patients will receive 120,000 hUTC
Cohort C
EXPERIMENTALPhase 1: 3 patients will receive 300,000 hUTC
Cohort D
EXPERIMENTALPhase 1: 3 patients will receive 560,000 hUTC
Cohort E
EXPERIMENTALPhase 1: 6 patients will receive 300,000 hUTC
Cohort F
EXPERIMENTALPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Cohort G
EXPERIMENTALPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Phase 2a
EXPERIMENTALUp to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study
Interventions
CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment. During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
Eligibility Criteria
You may qualify if:
- Women must be incapable of childbearing
- Patient must be 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
- Confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration
You may not qualify if:
- Evidence of exudative ("wet") age -related macular degeneration in either eye
- Evidence of other significant ophthalmologic disease (eg, glaucoma)
- Ocular hypertension
- Previous cell therapy other than blood components
- Previous treatment for age-related macular degeneration (AMD) other than antioxidant or zinc supplements or other oral vitamin supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Arcadia, California, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
October 22, 2010
Study Start
October 21, 2010
Primary Completion
March 31, 2015
Study Completion
May 31, 2017
Last Updated
August 8, 2017
Record last verified: 2017-08