June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Prospective Audit of Outcomes of Treatment of Exudative Age-Related Macular Degeneration: The Fight Retinal Blindness Project
Author Affiliations & Notes
  • Mark Gillies
    Ophthalmology, University of Sydney, Sydney, NSW, Australia
  • Daniel Barthelmes
    Ophthalmology, University of Sydney, Sydney, NSW, Australia
    Ophthalmology, University Hospital, Zurich, Switzerland
  • Footnotes
    Commercial Relationships Mark Gillies, Novartis (R), Pfizer (R), Allergan (F), Bayer (F); Daniel Barthelmes, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 3824. doi:
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      Mark Gillies, Daniel Barthelmes, ; Prospective Audit of Outcomes of Treatment of Exudative Age-Related Macular Degeneration: The Fight Retinal Blindness Project. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3824.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To report the 12-month outcomes of 1073 treatment-naive patients with exudative age-related macular degeneration (wet AMD) who were treated with anti-VEGF drugs audited in routine clinical practice. We tested the hypothesis that eyes treated in routine practice have similar results to those reported by the pivotal phase III studies, MARINA and ANCHOR

Methods: This database study analyzed outcomes from a prospectuvely designed database of a cohort of patients with wet AMD. Index visit characteristics, such as lesion size and type, visual acuity (VA) (LogMAR letters), as well as treatments, outcomes (VA, change in lesion activity status) and ocular adverse events were continually and anonymously recorded in an electronic database for 12 months. Primary outcome measures were change in VA after 12 months and number of treatments administered. Secondary outcomes included ocular adverse events and predictors of 12-month outcomes.

Results: Data from 1073 patients that were contributed by 27 retinal specialists across Australia working in routine clinical practice were analyzed. Mean change in VA in the entire cohort was +3.7 letters (95% CI: 2.4-5) which was achieved with a mean of 7.3 injections. When cohorts of patients from the observational study were selected that matched entry criteria for the MARINA (n=222) and ANCHOR (n=94) studies, the mean improvement in the matched observational cohort was very similar to that of the treatment group from the MARINA study, but not the ANCHOR study. No significant differences were found when results of change in VA and number of injections were analyzed with respect to lesion type or size. The median time to first the visit that the lesion was graded "inactive" was 191 days

Conclusions: These findings indicate that VEGF inhibitors can achieve reasonably good outcomes for wet AMD when used in routine clinical practice. The comparision of matched patients from the observational cohort with the treatment groups of the two pivotal phase III studies indicated that the results of at least one of these may be achievable in the real world.

Keywords: 412 age-related macular degeneration • 462 clinical (human) or epidemiologic studies: outcomes/complications • 503 drug toxicity/drug effects  
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