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 range18 Years

SexALL

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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

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

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