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

NCT ID: NCT01226628

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-21
• Study Completion Date: 2017-05-31

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).

Detailed Description

The study is a Phase 1/2a, multicenter, randomized (the study medication is assigned by chance), single dose, dose escalation, fellow-eye controlled study evaluating the safety and clinical response of a single, subretinal administration of CNTO 2476 in patients with visual acuity impairment associated with GA secondary to AMD. The study will consist of screening (up to 21 days prior to treatment) period, treatment (Day 1) period and follow up period. The study will be conducted in 2 portions: the Phase 1 portion will include dose escalation and the Phase 2 portion will enroll additional patients randomized to one of the 2 optimal doses selected from the Phase 1 portion (with an acceptable safety profile seen in Phase 1). For Phase 1, the treatment eye will be the eye with worse visual acuity or the one chosen by the investigator, however, the treatment eye cannot have a visual acuity no better than 20/200. For Phase 2a, the treatment eye will be the eye with worse visual acuity, and cannot have a visual acuity better than 20/80. Approximately 30 patients will participate in the Phase 1 dose escalation portion, and 38 patients will be enrolled in the Phase 2a portion (19 patients receiving optimal dose level X from Phase 1 and 19 receiving optimal dose level Y from Phase 1). In the Phase 1 portion, treatment will be assigned 5 sequential cohorts, with 3 patients per cohort in each of the first 4 cohorts and 6 patients in the fifth cohort. Cohort A patients will be treated first, followed by Cohort B patients. All patients in a given cohort must have completed at least 4 weeks of post-treatment follow-up before patients in the next cohort may be treated. Follow-up will include postoperative follow-up period of 12 months (Day 2, Day 7, Day 15, Week 3, Week 4, Months 2, 3, 6, and 12) and long-term safety follow-up period (patients will be evaluated every 6 months for safety assessments). Safety assessments will include vital signs, AEs, and concomitant medications and routine 12-lead electrocardiograms (ECG). The anticipated study duration will be approximately 5 years (1 year in the 12-month postoperative follow-up period; up to 4 years in the long-term safety follow-up period).

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

Phase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort B

Phase 1: 3 patients will receive 120,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort C

Phase 1: 3 patients will receive 300,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort D

Phase 1: 3 patients will receive 560,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort E

Phase 1: 6 patients will receive 300,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort F

Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Cohort G

Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Phase 2a

Up to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study

Group Type: EXPERIMENTAL

CNTO 2476

Intervention Type: BIOLOGICAL

iTrack Model 275 micro catheter

Intervention Type: PROCEDURE

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.

Interventions

CNTO 2476

Intervention Type: BIOLOGICAL

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.

Intervention Type: PROCEDURE

Other Intervention Names

Palucorcel

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arcadia, California, United States

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CNTO2476MDG1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR017548

Identifier Type: -

Identifier Source: org_study_id