Directional Spread in Geographic Atrophy

NCT ID: NCT02051998

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2019-11-30

Brief Summary

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. In the late stages of the disease, neovascular changes or the development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. The pathogenesis is still incompletely understood. Despite the break-through in the treatment of neovascular AMD by intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is yet no treatment available to slow down or halt the disease process in GA. We and others have demonstrated that the total GA area progression shows large differences between patients. Potential factors influencing differential progression have been intensely studied: While neither systemic nor genetic factors have been shown to influence GA progression, ocular characteristics such as GA baseline size or phenotypic features of fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for increased GA progression. While these previous studies have mainly focused on the characterization of total GA area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. There may be large differences in the local GA progression. The primary objective of this study is to identify specific characteristics, for the local GA progression. The knowledge of such risk factors may help to better understand the pathogenesis of GA. The identification of predictive markers will allow for better prognostic assessment of the individual disease process. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).

Conditions

Nonexudative Age-related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Men and women, any race, aged 55 years or older at the baseline visit
• If both eyes meet the criteria to be study eye either eye will be included into the analysis.
• Patient is willing to undergo ocular examinations once every 6 for up to 24 months

Exclusion Criteria

• The presence or history of CNV (choroidal neovascular membrane) in the study eye
• Ocular disease in the study eye that may confound assessment of the retina, other than non-exudative AMD (e.g., diabetic retinopathy, uveitis)
• Any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease).
• Any condition that would make adherence to the examination schedule of once every 6 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse
• Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Monika Fleckenstein, MD

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monika Fleckenstein, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, University of Bonn

Locations

Department of Ophthalmology, University of Bonn

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

References

Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22.

Reference Type: BACKGROUND

PMID: 17239336 (View on PubMed)

Schmitz-Valckenberg S, Bultmann S, Dreyhaupt J, Bindewald A, Holz FG, Rohrschneider K. Fundus autofluorescence and fundus perimetry in the junctional zone of geographic atrophy in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4470-6. doi: 10.1167/iovs.03-1311.

Reference Type: BACKGROUND

PMID: 15557456 (View on PubMed)

Fleckenstein M, Adrion C, Schmitz-Valckenberg S, Gobel AP, Bindewald-Wittich A, Scholl HP, Mansmann U, Holz FG; FAM Study Group. Concordance of disease progression in bilateral geographic atrophy due to AMD. Invest Ophthalmol Vis Sci. 2010 Feb;51(2):637-42. doi: 10.1167/iovs.09-3547. Epub 2009 Sep 24.

Reference Type: BACKGROUND

PMID: 19797219 (View on PubMed)

Schmitz-Valckenberg S, Brinkmann CK, Alten F, Herrmann P, Stratmann NK, Gobel AP, Fleckenstein M, Diller M, Jaffe GJ, Holz FG. Semiautomated image processing method for identification and quantification of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7640-6. doi: 10.1167/iovs.11-7457.

Reference Type: BACKGROUND

PMID: 21873669 (View on PubMed)

Fleckenstein M, Charbel Issa P, Helb HM, Schmitz-Valckenberg S, Finger RP, Scholl HP, Loeffler KU, Holz FG. High-resolution spectral domain-OCT imaging in geographic atrophy associated with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):4137-44. doi: 10.1167/iovs.08-1967. Epub 2008 May 16.

Reference Type: BACKGROUND

PMID: 18487363 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Adrion C, Kramer I, Eter N, Helb HM, Brinkmann CK, Charbel Issa P, Mansmann U, Holz FG. Tracking progression with spectral-domain optical coherence tomography in geographic atrophy caused by age-related macular degeneration. Invest Ophthalmol Vis Sci. 2010 Aug;51(8):3846-52. doi: 10.1167/iovs.09-4533. Epub 2010 Mar 31.

Reference Type: BACKGROUND

PMID: 20357194 (View on PubMed)

Fleckenstein M, Schmitz-Valckenberg S, Martens C, Kosanetzky S, Brinkmann CK, Hageman GS, Holz FG. Fundus autofluorescence and spectral-domain optical coherence tomography characteristics in a rapidly progressing form of geographic atrophy. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3761-6. doi: 10.1167/iovs.10-7021.

Reference Type: BACKGROUND

PMID: 21310912 (View on PubMed)

Schmitz-Valckenberg S, Fleckenstein M, Helb HM, Charbel Issa P, Scholl HP, Holz FG. In vivo imaging of foveal sparing in geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3915-21. doi: 10.1167/iovs.08-2484. Epub 2009 Apr 1.

Reference Type: BACKGROUND

PMID: 19339734 (View on PubMed)

Kunzel SH, Broadbent E, Moller PT, Lindner M, Goerdt L, Czauderna J, Schmitz-Valckenberg S, Holz FG, Pfau M, Fleckenstein M. Association of Lesion Location and Functional Parameters with Vision-Related Quality of Life in Geographic Atrophy Secondary to Age-related Macular Degeneration. Ophthalmol Retina. 2024 Aug;8(8):794-803. doi: 10.1016/j.oret.2024.01.025. Epub 2024 Feb 3.

Reference Type: DERIVED

PMID: 38311207 (View on PubMed)

Kunzel SH, Moller PT, Lindner M, Goerdt L, Nadal J, Schmid M, Schmitz-Valckenberg S, Holz FG, Fleckenstein M, Pfau M. Determinants of Quality of Life in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):63. doi: 10.1167/iovs.61.5.63.

Reference Type: DERIVED

PMID: 32462198 (View on PubMed)

Pfau M, von der Emde L, Dysli C, Thiele S, Moller PT, Lindner M, Nadal J, Schmid M, Schmitz-Valckenberg S, Holz FG, Fleckenstein M. Light Sensitivity Within Areas of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2019 Sep 3;60(12):3992-4001. doi: 10.1167/iovs.19-27178.

Reference Type: DERIVED

PMID: 31560765 (View on PubMed)

Pfau M, Lindner M, Goerdt L, Thiele S, Nadal J, Schmid M, Schmitz-Valckenberg S, Sadda SR, Holz FG, Fleckenstein M; Fundus Autofluorescence in Age-Related Macular Degeneration Study Group. PROGNOSTIC VALUE OF SHAPE-DESCRIPTIVE FACTORS FOR THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2019 Aug;39(8):1527-1540. doi: 10.1097/IAE.0000000000002206.

Reference Type: DERIVED

PMID: 29781974 (View on PubMed)

Lindner M, Kosanetzky S, Pfau M, Nadal J, Gordt LA, Schmitz-Valckenberg S, Schmid M, Holz FG, Fleckenstein M; FAM-Study Group. Local Progression Kinetics of Geographic Atrophy in Age-Related Macular Degeneration Are Associated With Atrophy Border Morphology. Invest Ophthalmol Vis Sci. 2018 Mar 20;59(4):AMD12-AMD18. doi: 10.1167/iovs.17-23203.

Reference Type: DERIVED

PMID: 29558533 (View on PubMed)

Fleckenstein M, Mitchell P, Freund KB, Sadda S, Holz FG, Brittain C, Henry EC, Ferrara D. The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmology. 2018 Mar;125(3):369-390. doi: 10.1016/j.ophtha.2017.08.038. Epub 2017 Oct 27.

Reference Type: DERIVED

PMID: 29110945 (View on PubMed)

Lindner M, Nadal J, Mauschitz MM, Luning A, Czauderna J, Pfau M, Schmitz-Valckenberg S, Holz FG, Schmid M, Fleckenstein M. Combined Fundus Autofluorescence and Near Infrared Reflectance as Prognostic Biomarkers for Visual Acuity in Foveal-Sparing Geographic Atrophy. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO61-BIO67. doi: 10.1167/iovs.16-21210.

Reference Type: DERIVED

PMID: 28475704 (View on PubMed)

Lindner M, Bezatis A, Czauderna J, Becker E, Brinkmann CK, Schmitz-Valckenberg S, Fimmers R, Holz FG, Fleckenstein M. Choroidal thickness in geographic atrophy secondary to age-related macular degeneration. Invest Ophthalmol Vis Sci. 2015 Jan 13;56(2):875-82. doi: 10.1167/iovs.14-14933.

Reference Type: DERIVED

PMID: 25587059 (View on PubMed)

Related Links

http://www.augenklinik.uni-bonn.de/

Webpage of the University Eye Hospital of Bonn

Other Identifiers

FL 658/4-1 and FL 658/4-2

Identifier Type: -

Identifier Source: org_study_id