Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004679

Trial Description

start of 1:1-Block title

Title

Intracameral concentrations of the fibrinolytic system components in patients with
age-related macular degeneration.

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

[---]*

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

Brief Summary in Lay Language

To detect the concentrations and activities of plasminogen and other components of the fibrinolytic system in fluid of the anterior chamber of the eye and to demonstrate significantly higher levels and activities of those components in patients with age-related macular degeneration (AMD) in comparison to healthy controls.
Therefor at the beginning of a cataract removal (phacoemulsification) procedure fluid will be harvested out of the anterior chamber.
An elevation of intraocular plasminogen in patients suffering from AMD might provide the rationale for intravitreal plasminogen activator application to induce a complete PVD. This in turn has a positive prognostic and therapeutic impact for patients with exsudative age-related macular degeneration. After the induction of posterior vitreous detachment visula acuity was demonstrated to improve and progression of macular changes are stopped.

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

Brief Summary in Scientific Language

The pathophysiological sequences within the vitreomacular interface (VMI) play, beside other mechanisms, a crucial role in the occurrence and progression rate of age-related macular degeneration (AMD). An attached or just partially detached posterior vitreous cortex (PVC) triggers those processes, whereas a completely detached PVC counteracts the traction-induced alterations in the VMI. Hence, the induction of a complete posterior vitreous detachment (PVD) is, beside other options, one of the fruitful feasibilities in the treatment strategy for AMD patients with vitreomacular adhesion (VMA). Beside pars plana vitrectomy (ppV), enzymatic vitreolysis can be used for PVD induction and major advantages have been attributed to this technique. Intravitreally administered recombinat tissue plasminogen activator (rTPA) has the potential to separate the PVC from the internal limiting membrane (ILM) of the neurosensory retina. For this purpose, intraocular plasminogen is needed, which in turn is activated by t-PA to plasmin. Plasmin, an active serine proteasis, degrades laminin and fibronectin at the VMI, thus inducing a complete PVD development.
The purpose of this study was to detect the intracameral concentrations and activities of plasminogen and other components of the fibrinolytic system and to demonstrate significantly higher levels and activities of those components in patients with AMD due to a blood-retina-barrier-breakdown (BRB) in comparison to healthy controls. An elevation of intraocular plasminogen activity in patients suffering from AMD might provide the rationale for intravitreal t-PA application to induce a complete PVD and thus antagonizing the pathophysiological sequences in the VMI, being triggered by an attached or just partially detached PVC (anomalous PVD).

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

Organizational Data

  •   DRKS00004679
  •   2013/01/29
  •   [---]*
  •   yes
  •   Approved
  •   94/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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

  •   H35.3 -  Degeneration of macula and posterior pole
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients suffering from exsudative age-related macular degeneration.
    Aspiration of anterior chamber fluid during routine cataract removal procedure.
  •   Patients suffering from dry age-related macular degeneration.
    Aspiration of anterior chamber fluid during routine cataract removal procedure.
  •   Healthy controls without age-related macular degeneration.
    Aspiration of anterior chamber fluid during routine cataract removal procedure.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Detection of intrcameral plasminogen activity

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

Secondary Outcome

Detection of concentrations and activities of different fibrinolytic system components.
(Plasminogen-activator-inhibitor I (PAI-1), alpha2-antiplasmin, plasmin-a2-antiplasmin complex (PAP) )

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 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/02/01
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   100   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

age-related macular degeneration, cataract

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

Exclusion Criteria

neoplasias
high myopia
patient younger 40 years
other eye diseases (diabetic retinopathy, h/o retinal detachment, uveitis, glaucoma)

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • UKGM GmbH, Standort Marburg, Augenklinik
    • Mr.  Dr. med.  Thomas  Bertelmann 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • UKGM GmbH, Standort Marburg, Augenklinik
    • Mr.  Dr. med.  Thomas  Bertelmann 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • UKGM GmbH, Standort Marburg, AUgenklinik
    • Mr.  Dr. med.  Thomas  Bertelmann 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
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
    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Baldingerstraße
    • 35033  Marburg
    • 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 complete, follow-up complete
  •   2011/02/01
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.