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Age-related Macular DegenerationPhase 1/2NCT01226628

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

A Phase 1/2 study testing CNTO 2476 and iTrack Model 275 micro catheter in people with Age-related Macular Degeneration, run by Janssen Research & Development, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
CNTO 2476 and iTrack Model 275 micro catheter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesUnited States
Study dates
21 Oct 2010to 31 May 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Arcadia, California

  • Study site

    Philadelphia, Pennsylvania

Other trials in United States

About this study

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

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).

Read the 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).

Being tested
CNTO 2476, iTrack Model 275 micro catheter
Keywords
Macular degeneration, Age-related macular degeneration, Cell therapy, CNTO 2476, Human umbilical tissue-derived cells, hUTC, Geographic Atrophy, Subretinal, Visual Acuity
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNTO 2476Biological

    Also called Palucorcel

  • iTrack Model 275 micro catheterProcedure or surgery

    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.

Study groups in NCT01226628
Study groupRoleWhat they receive
Cohort AExperimentalPhase 1: 3 patients will receive 60,000 human umbilical tissue-derived cells (hUTC)
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort BExperimentalPhase 1: 3 patients will receive 120,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort CExperimentalPhase 1: 3 patients will receive 300,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort DExperimentalPhase 1: 3 patients will receive 560,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort EExperimentalPhase 1: 6 patients will receive 300,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort FExperimentalPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Cohort GExperimentalPhase 1: 6 patients will receive either 60,000 or 300,000 hUTC
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter
Phase 2aExperimentalUp to 38 patients will receive one of two optimal doses as selected from the Phase 1 portion of the study
Receives: Biological: CNTO 2476; Procedure: iTrack Model 275 micro catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (5)

  1. Change from baseline in antibody peak values

    Measured: Baseline (Screening), up to 60 months

  2. Yearly rate of increase from baseline in area of Geographic Atrophy (GA)

    Measured: Baseline (Screening), up to 60 months

  3. Changes from baseline in visual function

    Changes from baseline in visual function is measured as changes in best corrected visual acuity [BCVA], low luminance BCVA, low luminance deficit, reading speed, contrast threshold, visual field and retinal thickness measured by spectral-domain optical coherence tomography (SD-OCT) at registered sections of the macula that include the geographic atrophy and adjacent retina

    Measured: Baseline (Screening), up to 60 months

  4. Change from baseline in Visual Functioning Questionnaire (VFQ)-25

    The VFQ-25 is a reliable and validated 25-item version of the larger 51-item National Eye Institute Visual Function Questionnaire. The questionnaire must be administered by the study staff and must not be self-administered. Analysis of VFQ-25 questionnaire data will be based on the thirteen sub-scales and a composite score.

    Measured: Baseline (Screening), up to 60 months

  5. Incidence of adverse events

    Incidence of adverse events will be assessed in both Phases (Phase 1 and Phase 2a)

    Measured: up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study start21 Oct 2010
  3. Primary completion31 Mar 2015
  4. Study completion31 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226628
Sponsor's protocol ID
CR017548
Other IDs
CNTO2476MDG1002
Status last verified
Aug 2017
First submitted
21 Oct 2010
Last updated
8 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CNTO 2476 and iTrack Model 275 micro catheter in people with Age-related Macular Degeneration, run by Janssen Research & Development, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of eyes with serious ocular adverse events occurring over the first 12 months of the study (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.

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