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A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration

NCT01226628 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-08-08

No results posted yet for this study

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).

Conditions

  • Age-related Macular Degeneration

Interventions

BIOLOGICAL

CNTO 2476

PROCEDURE

iTrack Model 275 micro catheter

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-21
Primary Completion
2015-03-31
Completion
2017-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226628 on ClinicalTrials.gov