Reticular Pseudodrusen Progression Study

NCT ID: NCT02345317

Last Updated: 2015-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Eter, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, University Medical Center Muenster

Locations

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Department of Ophthalmology, University Medical Center Muenster

Münster, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Florian Alten, MD

Role: CONTACT

+492518356001

Silvia Falkenau

Role: CONTACT

+492518356048

Facility Contacts

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Florian Alten, MD

Role: primary

+492518356001

References

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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.

Reference Type BACKGROUND
PMID: 25146989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24276561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23599330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22918638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22466490 (View on PubMed)

Other Identifiers

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AltenAugenklinik

Identifier Type: -

Identifier Source: org_study_id

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