ArticleOphthalmology science
Longitudinal Analysis of Mesopic Microperimetry in a Phase II Trial Evaluating Minocycline for Geographic Atrophy.
Article in Ophthalmology science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02564978 (Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To analyze mesopic microperimetry data from a recent phase II trial of minocycline for geographic atrophy (GA) for possible efficacy on the change in visual function and, in the absence of efficacy, to perform longitudinal analyses as a natural history study. Design: Phase II, prospective, single-arm, nonrandomized trial. After a 9-month run-in phase, participants began oral minocycline 100 mg twice daily for 3 years. Participants: Individuals with GA in ≥1 eye. Methods: Participants underwent mesopic microperimetry at baseline, month 3, and every 6 months thereafter, using a custom T-shaped test pattern. Rates of change in microperimetry parameters were compared between the 24-month treatment phase and 9-month run-in phase by linear spline regression. Main Outcome Measures: The mean macular and responding sensitivity; the mean perilesional and extralesional sensitivity; number of absolute and relative scotomatous loci. Results: Thirty study eyes from 30 participants (mean age 74.1 years) underwent microperimetry (mean follow-up 27.4 months). For 5 of the 6 microperimetry parameters, no significant difference in the rate of change between the treatment and run-in phases was observed. The difference between the 2 phases was -0.74 decibels (dB)/year (standard error [SE] 0.85; Conclusions: The results do not appear consistent with a clinically meaningful effect of minocycline on the rate of visual function decline from GA progression. This is consistent with previous analyses of the corresponding structural data. The findings demonstrate the advantages and disadvantages of different microperimetry parameters. The optimal testing patterns and parameters represent a trade-off between greater sensitivity vs. greater risk of floor/ceiling effects, with regional averages providing a useful compromise. The results may provide insights to guide the development of microperimetry end points for clinical trials. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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