Reticular Pseudodrusen Progression Study

Age-related Macular Degeneration Clinical Trial

Official title:

Reticular Pseudodrusen Progression Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345317
• Other study ID #: AltenAugenklinik
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 19, 2015
• Start date: December 2014

Study information

• Verified date: January 2015
• Source: University Hospital Muenster
• Contact: Florian Alten, MD
• Phone: +492518356001
• Email: florian.alten[@]ukmuenster.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University Medical Center Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of reticular pseudodrusen affected retinal area to baseline		24 months	No