Oftalʹmologiâ (Mar 2018)

Efficiency of Retinoprotective Dry AMD Therapy with Neuroprotective Therapy: a Randomized Clinical Trials Meta-analysis

  • V. P. Erichev,
  • S. Yu. Petrov,
  • A. V. Volzhanin

DOI
https://doi.org/10.18008/1816-5095-2018-1-69-79
Journal volume & issue
Vol. 15, no. 1
pp. 69 – 79

Abstract

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Article retracted.Рurpose. А meta-analysis of randomized clinical trials of efficiency and safety of retinalamin water-soluble polypeptide retinal fractionscomplex neuroprotective therapy in patients with dry age-related macular degeneration (amd), conducted in russia. Мethods. Published results of various clinical trials were searched by a single investigator using the “scientific electronic library” (elibrary.ru). meta-analysis included all clinical trials of retinalamin efficacy, where its route of administration and dosage corresponded with the guidelines for medical use of retinalamin in patients with dry amd. Results. Primary search revealed 320 publications concerning retinalamin. 11 of those presented results of randomized clinical trial that satisfied the requirements, and hence were included into the meta-analysis. beside the parabulbar and intramuscular administration, prescribed officially, retinalamin was also administered subconjunctivally, with electrophoresis and with subcutaneous injections in temporal zone. in three studies the observation period is 3 months, in one study it is 5 months, in four studies it is 6 months, and in two studies it is 12 months. in the rest of studies the observation period is less than 3 months. all the studies present the changes in visual acuity right after the therapy course. meta-analysis revealed a statistically significant visual acuity improvement, best discernible in patients with areds 3 amd stage up to 6 months after retinalamin treatment. the positive dynamics in visual acuity changing persists during the first 3 months. repeatedtherapy courses in 3–6 months provided further progress. perimetry revealed the increasing of visual field borders and decreasingof central scotomae amount and area; the findings have also improved after the repeated course. the electrophysiology studyingshowed the positive dynamics as well and correlated with visual acuity changes. optical coherence tomography, blood flow examination and a series of other tests were also used. however, varying diagnostic methods in different trials as well as a low level of statistical data processing, impeded the fulfillment of a comprehensive analysis. Conclusion. Randomized clinical trial meta-analysis proved the efficacy of retinalamin therapy in patients with dry amd

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