Directional Spread in Geographic Atrophy

Completed

• Conditions: Nonexudative Age-related Macular Degeneration

• Registration Number: NCT02051998
• Lead Sponsor: University Hospital, Bonn

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Status Verified: 2019-11
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of geographic atrophy size to baseline	24 months

Secondary Outcome Measures

Name	Time	Method
Change in BCVA from baseline	24 months

Trial Locations

Locations (1)

Department of Ophthalmology, University of Bonn; 🇩🇪 Bonn, NRW, Germany