NCT02345317

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

January 19, 2015

Last Update Submit

January 19, 2015

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change of reticular pseudodrusen affected retinal area to baseline

    24 months

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Medical Center Muenster

Münster, 48149, Germany

RECRUITING

Related Publications (5)

  • Alten F, Heiduschka P, Clemens CR, Eter N. Longitudinal structure/function analysis in reticular pseudodrusen. Invest Ophthalmol Vis Sci. 2014 Aug 21;55(9):6073-81. doi: 10.1167/iovs.13-13804.

    PMID: 25146989BACKGROUND

  • Alten F, Clemens CR, Heiduschka P, Eter N. Characterisation of reticular pseudodrusen and their central target aspect in multi-spectral, confocal scanning laser ophthalmoscopy. Graefes Arch Clin Exp Ophthalmol. 2014 May;252(5):715-21. doi: 10.1007/s00417-013-2525-y. Epub 2013 Nov 26.

    PMID: 24276561BACKGROUND

  • Alten F, Clemens CR, Heiduschka P, Eter N. Localized reticular pseudodrusen and their topographic relation to choroidal watershed zones and changes in choroidal volumes. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3250-7. doi: 10.1167/iovs.13-11923.

    PMID: 23599330BACKGROUND

  • Alten F, Heiduschka P, Clemens CR, Eter N. Multifocal electroretinography in eyes with reticular pseudodrusen. Invest Ophthalmol Vis Sci. 2012 Sep 14;53(10):6263-70. doi: 10.1167/iovs.12-10094.

    PMID: 22918638BACKGROUND

  • Alten F, Clemens CR, Milojcic C, Eter N. Subretinal drusenoid deposits associated with pigment epithelium detachment in age-related macular degeneration. Retina. 2012 Oct;32(9):1727-32. doi: 10.1097/IAE.0b013e3182475b03.

    PMID: 22466490BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Nicole Eter, Prof

    Department of Ophthalmology, University Medical Center Muenster

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Alten, MD

CONTACT

+492518356001florian.alten@ukmuenster.de

Silvia Falkenau

CONTACT

+492518356048silvia.falkenau@ukmuenster.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

DE(1)