Nonexudative Age-related Macular DegenerationDSGANCT02051998
Directional Spread in Geographic Atrophy
An observational study of Nonexudative Age-related Macular Degeneration, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Nonexudative Age-related Macular Degeneration
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suitable for the study will be recruited at the University of Bonn, Department of Ophthalmology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology, University of Bonn
Bonn, North Rhine-Westphalia, 53127
About this study
Official title: Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
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).
- Keywords
- Geographic atrophy, Age-related macular degeneration, Retina, Retinal pigment epithelium, Optical coherence tomography, Scanning laser ophthalmoscopy
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of geographic atrophy size to baseline
Measured: 24 months
Secondary outcomes (1)
Change in BCVA from baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Nonexudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Monika Fleckenstein, MD, University Hospital, Bonn
- Investigators
- Monika Fleckenstein, Prof. Dr. med., Principal investigator, Department of Ophthalmology, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051998
- Sponsor's protocol ID
- FL 658/4-1 and FL 658/4-2
- Acronym
- DSGA
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2014
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17239336Schmitz-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.
PubMed 15557456Fleckenstein 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.
PubMed 19797219Schmitz-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.
PubMed 21873669Fleckenstein 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.
PubMed 18487363Fleckenstein 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.
PubMed 20357194Fleckenstein 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.
PubMed 21310912Schmitz-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.
PubMed 19339734Kunzel 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.
PubMed 38311207Kunzel 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.
PubMed 32462198Pfau 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.
PubMed 31560765Pfau 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.
PubMed 29781974Lindner 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.
PubMed 29558533Fleckenstein 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.
PubMed 29110945Lindner 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.
PubMed 28475704
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT02051998
- Acronym / sponsor ID
- DSGA / FL 658/4-1 and FL 658/4-2
- Keywords
- Geographic atrophy, Age-related macular degeneration, Retina, Retinal pigment epithelium, Optical coherence tomography, Scanning laser ophthalmoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suitable for the study will be recruited at the University of Bonn, Department of Ophthalmology
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of geographic atrophy size to baseline
Time frame: 24 months
1 secondary outcome
Change in BCVA from baseline
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 17239336Holz 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.
- Background: PubMed 15557456Schmitz-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.
- Background: PubMed 19797219Fleckenstein 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.
- Background: PubMed 21873669Schmitz-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.
- Background: PubMed 18487363Fleckenstein 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.
- Background: PubMed 20357194Fleckenstein 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.
- Background: PubMed 21310912Fleckenstein 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.
- Background: PubMed 19339734Schmitz-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.
- Derived from this study: PubMed 38311207Kunzel 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.
- Derived from this study: PubMed 32462198Kunzel 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.
- Derived from this study: PubMed 31560765Pfau 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.
- Derived from this study: PubMed 29781974Pfau 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.
- Webpage of the University Eye Hospital of BonnLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Fleckenstein, Prof. Dr. med. principal investigator
Department of Ophthalmology, University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonexudative Age-related Macular Degeneration, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of geographic atrophy size to baseline (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051998, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.