Sparing of the Fovea in Geographic Atrophy Progression
Schlüsselwörter
Abstrakt
Termine
Zuletzt überprüft: | 04/30/2017 |
Zuerst eingereicht: | 01/03/2015 |
Geschätzte Einschreibung eingereicht: | 01/04/2015 |
Zuerst veröffentlicht: | 01/05/2015 |
Letztes eingereichtes Update: | 05/04/2017 |
Letztes Update veröffentlicht: | 05/07/2017 |
Tatsächliches Startdatum der Studie: | 09/30/2014 |
Geschätztes primäres Abschlussdatum: | 12/31/2016 |
Voraussichtliches Abschlussdatum der Studie: | 12/31/2016 |
Zustand oder Krankheit
Intervention / Behandlung
Other: No intervention - Natural history study
Phase
Zulassungskriterien
Altersberechtigt für das Studium | 55 Years Zu 55 Years |
Studienberechtigte Geschlechter | All |
Probenahmeverfahren | Non-Probability Sample |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | Inclusion Criteria: - Informed consent - The study eye must have a contiguous well-demarcated area of GA either in a complete ring around the spared fovea or in a horseshoe pattern with a total atrophy size of ≤ 7 Disk Areas - Patient is willing to undergo ocular examination 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) - Cataract surgery or ocular surgery in the study eye within 30 days prior to the baseline visit - Current or previous participation in clinical studies investigating drugs, medical devices or supplements within 30 days prior to enrolment in the study - Previous or concomitant therapy to reat AMD (investigational or FDA approved); oral supplements of vitamins and minerals are permitted - Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion |
Ergebnis
Primäre Ergebnismaße
1. Best corrected visual acuity (BCVA) [baseline]
Sekundäre Ergebnismaße
1. Size of Geographic atrophy area as determined by confocal laser scanning ophthalmoscopy (in mm²) [baseline]
2. Size of foveal sparing area as determined by confocal laser scanning ophthalmoscopy (in mm²) [baseline]