Overview

This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments cnto 2476, itrack model 275 micro catheter
Phase phase 1/phase 2
Sponsor Janssen Research & Development, LLC
Start date September 2010
End date March 2015
Trial size 39 participants
Trial identifier NCT01226628, CNTO2476MDG1002, CR017548

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Phase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 3 patients will receive 120,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 3 patients will receive 300,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 3 patients will receive 560,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 6 patients will receive 300,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Phase 1: 6 patients will receive either 60,000 or 300,000 hUTC
cnto 2476 Palucorcel
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.
(Experimental)
Up to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study
cnto 2476 Palucorcel
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.

Primary Outcomes

Measure
Number of eyes with serious ocular adverse events occurring over the first 12 months of the study
time frame: 12 months

Secondary Outcomes

Measure
Change from baseline in antibody peak values
time frame: Baseline (Screening), up to 60 months
Yearly rate of increase from baseline in area of Geographic Atrophy (GA)
time frame: Baseline (Screening), up to 60 months
Changes from baseline in visual function
time frame: Baseline (Screening), up to 60 months
Change from baseline in Visual Functioning Questionnaire (VFQ)-25
time frame: Baseline (Screening), up to 60 months
Incidence of adverse events
time frame: up to 60 months

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title 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
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 of 4 years (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; 4 years in the long-term safety follow-up period).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.