The South African macular oedema in diabetics study (the same study): a prospective randomized non-inferiority trial

Authors

  • Naseer Ally St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg http://orcid.org/0000-0002-6676-9352
  • Sarah Ismail St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Bongi P. Sithole St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Mpho Tsimanyane St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Ismail Mayet St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Tebogo R. Kgarebe St John Eyecare Clinic, Chris Hani Road, Soweto
  • Angelika U. Carey St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Taimeia G. Hussain St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg http://orcid.org/0000-0002-8514-7698
  • Craig D. Anderson St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg http://orcid.org/0000-0002-8918-367X
  • Kihagi Mwita St John Eye Hospital, Chris Hani Road Diepkloof, Soweto
  • Kashmira Rawjee St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Monique D.G. Camacho St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Melody W.L. Sun St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Thabiso Mofokeng St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Fathima Mitha St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Lintle Ntlou St John Eye Hospital, Chris Hani Road Diepkloof, Soweto
  • Ingrid Walters St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Hester Kruger St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Farai N. F. Mabunda St John Eye Hospital, Chris Hani Road Diepkloof, Soweto
  • Lieschen Branders St John Eye Hospital, Chris Hani Road Diepkloof, Soweto
  • Ismail Makda St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Wihan de Jager St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg
  • Hassan D. Alli University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg http://orcid.org/0000-0002-8687-0925

DOI:

https://doi.org/10.18203/2349-3259.ijct20204483

Keywords:

Bevacizumab, Diabetic macular oedema, Pro re nata, Treat and extend, Diabetic retinopathy, Anti-VEGF

Abstract

Background: Diabetic retinopathy is the most common cause of visual loss affecting the economically productive age group globally. Diabetic macular oedema (DMO) results from leakage of fluid into the retinal interstitial space. Anti-vascular endothelial growth factor (anti-VEGF) drugs are the first line treatment for DMO. Since monthly injections are required, this treatment regimen can prove very costly. Of the anti-VEGF drugs, bevacizumab is the most cost-effective. The pro re nata (PRN) method is the current standard of care. However, the treat and extend (T and E) regimen can potentially decrease the patient burden on hospitals. Thus far, no randomised clinical trials have been performed using Bevacizumab in a treat and extend versus pro re nata regimen.

Methods: A prospective randomised non-inferiority clinical trial testing bevacizumab (1.25 mg) in a treat and extend method versus the pro re nata method is being conducted. Patients will be randomised using a simple computer-based randomised algorithm. The primary outcome is non-inferiority within a five-letter margin for the T and E regimen versus the PRN regimen.

Conclusions: This study aims to inform a key area in the literature on the treatment of DMO, i.e. whether a T and E regimen is non-inferior to a PRN regimen in the treatment of DMO with bevacizumab, which is the only anti VEGF available in resource poor settings. It is motivated by the cost involved in the treatment of DMO as well as the treatment burden on both the patient and the health institution at which the patient is receiving treatment.

Trial registration: The trial has been registered on the Pan-African clinical trials registry (PACTR202001624880-753).

Author Biographies

Naseer Ally, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Consultant Ophthalmologist St John Eye Hospital                         

Sarah Ismail, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John eye hospital                       

Bongi P. Sithole, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar St John Eye Hospital                       

Mpho Tsimanyane, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital                      

Ismail Mayet, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Adjunct Professor, Head of department, St John Eye Hospital                     

Tebogo R. Kgarebe, St John Eyecare Clinic, Chris Hani Road, Soweto

Optometrist, St John eyecare clinic                    

Angelika U. Carey, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye hospital                   

Taimeia G. Hussain, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital                  

Craig D. Anderson, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital                 

Kihagi Mwita, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto

Medical Officer, St John Eye Hospital                

Kashmira Rawjee, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital               

Monique D.G. Camacho, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, South Africa              

Melody W.L. Sun, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital             

Thabiso Mofokeng, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital            

Fathima Mitha, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Consultant ophthalmologist, St John Eye Hospital           

Lintle Ntlou, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto

Medical officer, St John Eye Hospital          

Ingrid Walters, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital         

Hester Kruger, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital        

Farai N. F. Mabunda, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto

Medical officer, St John Eye Hospital       

Lieschen Branders, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto

Medical officer, St John Eye Hospital      

Ismail Makda, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital     

Wihan de Jager, St John Eye Hospital, Chris Hani Road Diepkloof, Soweto University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Registrar, St John Eye Hospital    

Hassan D. Alli, University of the Witwatersrand, Department of Neurosciences, Division of Ophthalmology, York road Parktown Johannesburg

Consultant Ophthalmologist, St John Eye Hospital   

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Published

2020-10-20