Trial document




drksid header

  DRKS00004522

Trial Description

start of 1:1-Block title

Title

Retina.net ROP Registry

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.rop-register.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The retina.net ROP registry is a German database aiming at storing and evaluating data concerning ROP treatment patterns and courses of disease after treatment. The background of this registry is the fact that currently several treatment options for ROP exist with in some cases only limited data concerning long-term outcomes. The registry is limited to observational data collection and will not interfere with treatment decisions. All infants with treated ROP are eligible for data entry, irrespective of the individual treatment received. Informed consent from parents regarding data storage and evaluation is a mandatory for data entry.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Registry to investigate treated ROP cases in Germany.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004522
  •   2012/10/30
  •   [---]*
  •   yes
  •   Approved
  •   268/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   retinopathy of prematurity (ROP)
  •   H35.1 -  Retinopathy of prematurity
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   retinal laser coagulation
  •   intravitreal injections
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

treatment patterns and course of disease after treatment

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

longterm functional outcomes

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/10/30
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

ROP requiring treatment

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

lack of informed consent for data acquisition, storage and evaluation for prospective registry

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Retinologische Gesellschaft Deutschland
    • 23552  Lübeck
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.