Trial reportTransactions of the American Ophthalmological Society2006
Preliminary analysis of the final multicenter investigation of rheopheresis for age related macular degeneration (AMD) trial (MIRA-1) results.
Trial report in Transactions of the American Ophthalmological Society, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue.Journal of clinical apheresis · 2026Guideline
- Interventions for age-related visual problems in patients with stroke.The Cochrane database of systematic reviews · 2012Pooled it
- [Rheopheresis for age-related macular degeneration].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2009Pooled it
- Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration. Dry AMD treatment with Rheopheresis Trial-ART.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2009Trial
- Review
- Complement pathway biomarkers and age-related macular degeneration.Eye (London, England) · 2016Review
- Preservation of the Photoreceptor Inner/Outer Segment Junction in Dry Age-Related Macular Degeneration Treated by Rheohemapheresis.Journal of ophthalmology · 2015Article
- Long-term outcomes of rheohaemapheresis in the treatment of dry form of age-related macular degeneration.Journal of ophthalmology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo present an initial evaluation of the final data from the Multicenter Investigation of Rheopheresis for age-related macular degeneration (AMD) (MIRA-1) trial. This was a 12-month randomized, prospective, multicenter, double-masked, placebo-controlled, Food and Drug Administration approved clinical trial designed to compare rheopheresis treatment with placebo-control treatment.
methodsPatients that had nonexudative age-related macular degeneration (AMD) and certain hemorheologic abnormalities were randomized to either rheopheresis or sham treatment in a 2:1 fashion. Best-corrected visual acuity was determined before and at 3, 6, 9, and 12 months following treatment. Adverse events were also recorded.
resultsA total of 216 patients were randomized. Of these, 18 were not included in the vision or adverse events evaluation because they did not complete one treatment. This decreased the number of patients that were evaluated for adverse events to 198 patients. In this group, there were 27 serious adverse events, but only 1.8 % of treatments were suspended because of adverse events. At 12 months, there were 104 treated patients and 63 placebo patients that had follow-up. The treated patients had a logMAR vision improvement of 0.02 +/- 0.213, and the placebo patients had a vision improvement of 0.02 +/- 0.20. This was not statistically significant (P = .977). The repeated measure P value for the entire time interval was not significant (P = .69). There appeared to be patients entered into the study that did not meet inclusion criteria. Excluding 37% of the treated patients and 29% of the placebo data from the analysis, there appeared to be statistically significant improvement in the treated patients compared to the control patients at 1 year with a P value of .001 (repeated measures P value = .01).
conclusionsAt best this was a flawed study in that 37% of the treated cases did not meet inclusion criteria, and at worst there was no evidence of effect. Even though the number of serious adverse events is small, because this study did not show an effect in the intent-to-treat group, rheopheresis should not be performed for AMD outside of an approved randomized controlled trial.
Indexed as
Identifiers
17471343PMC1809892W30837767What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.