Reticular Pseudodrusen Progression Study

January 19, 2015 updated by: University Hospital Muenster
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Muenster, Germany, 48149
        • Recruiting
        • Department of Ophthalmology, University Medical Center Muenster
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suitable for the study will be recruited at the University of Muenster, Department of Ophthalmology

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of reticular pseudodrusen affected retinal area to baseline
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AltenAugenklinik

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-related Macular Degeneration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe