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 Table of Contents  
AUTHORS' REPLY
Year : 2013  |  Volume : 1  |  Issue : 2  |  Page : 124-125

Authors' reply


1 Department of Ophthalmology, Hindu Rao Hospital, Delhi, India
2 Department of Medicine, Jag Pravesh Chandra Hospital, Delhi, India

Date of Web Publication20-May-2013

Correspondence Address:
Jatinder Bali
Department of Ophthalmology, Hindu Rao Hospital, Delhi
India
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Source of Support: None, Conflict of Interest: None


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How to cite this article:
Bali J, Bali RT. Authors' reply. J Clin Ophthalmol Res 2013;1:124-5

How to cite this URL:
Bali J, Bali RT. Authors' reply. J Clin Ophthalmol Res [serial online] 2013 [cited 2019 Oct 22];1:124-5. Available from: http://www.jcor.in/text.asp?2013/1/2/124/112184

Dear Editor,

I thank Koshy [1] for his keen interest in my article. [2] His observations are correct. We need to proceed with caution in the use of anti-vascular endothelial growth factors (VEGFs) or aptamers.

On one hand are the benefits of the emerging therapies and on the other are serious adverse effects which get reported only much later. Marcello Pagano said that 50% of what is being taught in medical schools today will be proved to have been wrong in 10-year-time, and we do not know which 50%. The concept of "bounded rationality" comes into play in such situations. This refers to decision making in uncertainty based only on the inputs or data available at that moment in time. Internet has been a great enabler, but it also enjoins every doctor to be better informed than his forefathers all the while following the principle of "Primum non-nocere."

Our ophthalmic experience with infliximab, or the gynaec experience with thalidomide goes to underline the need for caution. [3],[4] We are attaching the adverse effect statistics of RIDE [Table 1], RISE [Table 2], and RESTORE [Table 3] trials. [5],[6],[7]
Table 1: RIDE – Participant fl ow: Overall study

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Table 2: RISE – Participant fl ow: Overall study

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Table 3: RESTORE – Core study

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Serious adverse effects are usually a rare phenomenon. They need many different statistical methodologies and larger numbers for studying these than are possible in these trials. Observational longitudinal studies of drug use in any community are imperative for any drug. Comparability of results is possible if similar methods are followed and records are maintained assiduously. A wealth of information comes from Scandinavian countries and Framingham Heart Study. [8] In fact, a nationalized database for pharmacoepidemiology would not be out of place in a country like India given our large heterogeneous population, large number of clinical trials, our software experience and the need to collate quality data on the subject globally. We are also plagued by lack of interdisciplinary interaction in patient management. Hence, his suggestion of a standardized protocol for work up and reporting of adverse effects in patients contemplated to be given these medications is very welcome. That said, we need to interpret such data carefully. Under-reporting of adverse effects in general populations with anti-VEGFs is an attractive hypothesis but is not supported by evidence at the present moment in time.

 
  References Top

1.Koshy J. Are anti-VEGF drugs the panacea for all diabetic retinopathy patients? J Clin Ophthalmol Res 2013;1:123.  Back to cited text no. 1
    
2.Bali J, Bali RT. Pathological ocular angiogenesis in diabetes: A perspective of emerging paradigms and current evidence. J Clin Ophthalmol Res 2013;1:3-10.th   Back to cited text no. 2
    
3. Pulido JS, Pulido JE, Michet CJ, Vile RG. More questions than answers: A call for a moratorium on the use of intravitreal infliximab outside of a well-designed trial. Retina 2010;30:1-5.  Back to cited text no. 3
    
4.Giganti M, Beer PM, Lemanski N, Hartman C, Schartman J, Falk N. Adverse events after intravitreal infliximab (Remicade). Retina 2010;30:71-80.  Back to cited text no. 4
    
5.A 12 month core study to assess the efficacy and safety of ranibizumab (intravitreal injections) in patients with visual impairment due to diabetic macular edema and a 24 month open-label extension study (RESTORE). ClinicalTrials.gov Identifier: NCT00687804. Available from: http://www.clinicaltrials.gov/ct2/show/NCT00687804?term=restore+macula&rank=1. [Accessed on 2013 Mar 1].  Back to cited text no. 5
    
6.A study of ranibizumab injection in subjects with clinically significant macular edema (ME) with center involvement secondary to diabetes mellitus (RIDE). ClinicalTrials.gov Identifier: NCT00473382. Available from: http://www.clinicaltrials.gov/ct2/show/NCT00473382?term=RIDE&rank=2. [Accessed on 2013 Mar 1].  Back to cited text no. 6
    
7.A study of ranibizumab injection in subjects with clinically significant macular edema (ME) with center involvement secondary to diabetes mellitus (RISE). Available from: http://www.clinicaltrials.gov/ct2/show/NCT00473330?term=RISE+RANIBIZUMAB&rank=1. [Accessed on 2013 Mar 1].  Back to cited text no. 7
    
8.Dawber TR, Meadors GF, Moore FE. Epidemiological approaches to heart disease: The Framingham Study. Presented at a Joint Session of the Epidemiology, Health Officers, Medical Care, and Statistics Sections of the American Public Health Association, at the Seventy-Eighth Annual Meeting, St. Louis, MO; 1950.  Back to cited text no. 8
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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