Directional Spread in Geographic Atrophy (DSGA)
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ClinicalTrials.gov Identifier: NCT02051998 |
Recruitment Status :
Completed
First Posted : January 31, 2014
Last Update Posted : December 2, 2019
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Condition or disease |
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Nonexudative Age-related Macular Degeneration |
Study Type : | Observational |
Actual Enrollment : | 130 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD) |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | November 2019 |
Actual Study Completion Date : | November 2019 |

- Change of geographic atrophy size to baseline [ Time Frame: 24 months ]
- Change in BCVA from baseline [ Time Frame: 24 months ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051998
Germany | |
Department of Ophthalmology, University of Bonn | |
Bonn, NRW, Germany, 53127 |
Principal Investigator: | Monika Fleckenstein, Prof. Dr. med. | Department of Ophthalmology, University of Bonn |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof. Dr. Monika Fleckenstein, MD, Prof. Dr. med., University Hospital, Bonn |
ClinicalTrials.gov Identifier: | NCT02051998 |
Other Study ID Numbers: |
FL 658/4-1 and FL 658/4-2 |
First Posted: | January 31, 2014 Key Record Dates |
Last Update Posted: | December 2, 2019 |
Last Verified: | November 2019 |
Geographic atrophy Age-related macular degeneration Retina |
Retinal pigment epithelium Optical coherence tomography Scanning laser ophthalmoscopy |
Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |