TerminatedPhase 1

A Study to Evaluate the Safety of CNTO 2476 in Patients With Advanced Retinitis Pigmentosa

Stopped: Internal Business Decision

United States7 participantsStarted 2007-04

Plain-language summary

The main purpose of this study is to evaluate the preliminary safety and immunogenicity (ability of an antigen to provoke immune response in the human body) of CNTO 2476, administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of the eye that leads to loss of vision and blindness) with either light perception only (LP) or hand motion (HM).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of retinitis pigmentosa that is not part of another systemic disease * Vision deficit characterized by vision that is not better than either light perception (Group 1) or hand motion (Group 2) in both eyes * Normal hematology and chemistry lab results * Participant is suitable candidate for ophthalmologic surgery Exclusion Criteria: * Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination * Women of childbearing potential * Ocular hypertension * Other serious medical conditions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of adverse events as a measure of safety and tolerability

Timeframe: Up to 5 years from the time participant is eligible to enter study

Level of anti-CNTO 2476 antibody in blood for immunogenicity testing

Timeframe: Baseline, Days 7 and 15, Weeks 3 and 4, Months 2, 3, 6, 12, 24, 36, 48, and 60

Trial details

NCT IDNCT00458575

SponsorCentocor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Retinitis Pigmentosa trials