Reticular Pseudodrusen Progression Study

Sponsor
University Hospital Muenster (Other)
Overall Status
Unknown status
CT.gov ID
NCT02345317
Collaborator
(none)
30
1

Study Details

Study Description

Brief Summary

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional phenotypic characteristic frequently observed in patients with AMD. Several studies have proven that the prevalence of RPD is associated with AMD as well as a high risk of disease progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet still incompletely understood. Retrospective studies have demonstrated that the RPD affected retinal area increases over time. Potential factors influencing progression of RPD have not been intensely studied and potentially predictive markers are yet unknown. The primary objective of this study is to characterize RPD progression in more detail and to identify predictive markers of RPD progression and development of AMD late stages.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Reticular Pseudodrusen Progression Study
    Study Start Date :
    Dec 1, 2014
    Anticipated Primary Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Change of reticular pseudodrusen affected retinal area to baseline [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Informed consent

    • Men and women, any race, aged 60 years or older at the baseline visit

    • Presence of RPD without any other type of drusen, hypo/hyperpigmentation, geographic atrophy, choroidal neovascularization

    • Patient is willing to undergo ocular examinations once every 12 for up to 24 months

    Exclusion Criteria:
    • Presence or history of soft drusen, hypo-/hyperpigmentation, geographic atrophy or choroidal neovascularization in the study eye

    • Ocular disease in the study eye that may confound assessment of the retina (e.g., diabetic retinopathy, uveitis)

    • Any condition that would make adherence to the examination schedule of once every 12 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, University Medical Center Muenster Muenster Germany 48149

    Sponsors and Collaborators

    • University Hospital Muenster

    Investigators

    • Principal Investigator: Nicole Eter, Prof, Department of Ophthalmology, University Medical Center Muenster

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Hospital Muenster
    ClinicalTrials.gov Identifier:
    NCT02345317
    Other Study ID Numbers:
    • AltenAugenklinik
    First Posted:
    Jan 26, 2015
    Last Update Posted:
    Jan 26, 2015
    Last Verified:
    Jan 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2015