Jaffe, Glenn J; Schmitz-Valckenberg, Steffen; Boyer, David; Heier, Jeffrey; Wolf-Schnurrbusch, Ute; Staurenghi, Giovanni; Schmidt-Erfurth, Ursula; Holz, Frank G (2015). Randomized Trial to Evaluate Tandosporine in Geographic Atrophy Secondary to Age-Related Macular Degeneration: the GATE Study. American journal of ophthalmology, 160(6), pp. 1226-1234. Elsevier Science 10.1016/j.ajo.2015.08.024
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PURPOSE
To determine the safety and efficacy of AL-8309B (tandospirone) in the management of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and obtain standardized data on GA lesion growth progression.
DESIGN
Prospective, controlled, double-masked, randomized, multicenter phase 3 clinical trial.
METHODS
Setting: 48 clinical sites.
PATIENTS
Patients with GA associated with AMD were enrolled. All patients were followed for a minimum of 30 months, and up to 36 months. Intervention Procedures: Patients were randomized (1:1:1) to receive AL-8309B ophthalmic solution 1.0%, 1.75%, or vehicle, administered as a twice-daily topical ocular drop.
MAIN OUTCOME MEASURES
The primary efficacy endpoint was mean annualized lesion enlargement from baseline as assessed with fundus autofluorescence (FAF) imaging.
RESULTS
A total of 768 eyes of 768 patients were enrolled and treated with AL-8309B 1.0% (N=250), AL-8309B 1.75% (N=258), or vehicle (N= 260). An increase in mean lesion size was observed in both the AL-8309B and vehicle treatment groups, and growth rates were similar in all treatment groups. Annualized lesion growth rates were 1.73, 1.76 and 1.71 mm(2) for AL-8309B 1.0%, AL-8309B 1.75%, and vehicle, respectively.
CONCLUSIONS
AL-8309B 1.0% and 1.75% did not affect lesion growth in eyes with GA secondary to AMD. There were no clinically relevant safety issues identified for AL-8309B. The large natural history dataset from this study is a valuable repository for future comparisons.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology |
UniBE Contributor: |
Wolf-Schnurrbusch, Ute |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
0002-9394 |
Publisher: |
Elsevier Science |
Language: |
English |
Submitter: |
Sebastian Wolf |
Date Deposited: |
04 Dec 2015 17:33 |
Last Modified: |
05 Dec 2022 14:49 |
Publisher DOI: |
10.1016/j.ajo.2015.08.024 |
PubMed ID: |
26310670 |
BORIS DOI: |
10.7892/boris.71988 |
URI: |
https://boris.unibe.ch/id/eprint/71988 |
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