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Trial no.:
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PACTR202001624880753 |
Date of Approval:
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06/01/2020 |
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Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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| TRIAL DESCRIPTION |
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Public title
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The SAME Study |
| Official scientific title |
The South African Macular oEdema in diabetics study (The SAME Study): A prospective randomized non-inferiority trial |
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Brief summary describing the background
and objectives of the trial
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Diabetic Macular Oedema (DMO) is a leading cause of this visual loss among the diabetic population. Treatment modalities for DMO include laser and more recently intravitreal anti-VEGF (vascular endothelial growth factor) agents.
Ranibizumab (Lucentis, Genentech/Roche), a fragment of a monoclonal antibody that targets Vascular Endothelial Growth Factor (VEGF) has proven efficacious and superior to grid-laser in the treatment of DMO. As outcomes with anti-VEGF therapy are superior to grid-laser, anti-VEGF therapy is regarded as first line in the treatment of DMO. The challenge with using Ranibizumab, especially in the public sector, is the high cost involved. A precursor molecule from which Ranibizumab is manufactured, Bevacizumab (Avastin, Genentech/Roche), is currently used off-label for the treatment of DMO. Bevacizumab has also proven superior to laser in the treatment of DMO, although at a much lower cost than Ranibizumab. Aflibercept (Eyelea, Regeneron/Bayer HealthCare), is a new addition to the anti-VEGF family which has also shown efficacy in the treatment of DMO. The use of Aflibercept and Ranibizumab is not possible in resource limited setting due to the high cost factor and thus the first line treatment of DMO in resource limited settings is Bevacizumab.
An application by the International Council of Ophthalmology has been made to include the use of bevacizumab in treating retinal neovascular diseases (Appendix A). Multiple studies have used bevcizumab from as early as 2006. The Pan-American Collaborative Retina Study Group utilized bevacizumab as first line treatment in DMO and found good visual and anatomical outcomes with this anti-VEGF agent (Appendix B). The only study to date comparing the 3 available anti-VEGF agents is the DRCR.net protocol T study. Bevacizumab was found to be non-inferior to Ranibizumab in visual and anatomical outcomes.
Currently two regimens are utilized, the treat and extend (T&E) and the pro re nata (PRN) The T&E regimen has been proven to be non-inferior to the prn regimen when using Ranibizumab for the treatment of DMO. Advantages of the T&E regimen are that patients require fewer out-patient visits, thus decreasing the burden on already overextended public resources. The financial costs to patients and their families is also decreased. With less intravitreal injections, the risk of complications is also decreased.
As there are no African studies, our study aims to look at the outcomes of patients treated pro re nata (PRN) compared to patients treated with a treat and extend (T&E) protocol. This will assist with informed decision making and decrease the load on an already overburdened facility with limited resources.
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| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Eye Diseases |
| Sub-Disease(s) or condition(s) being studied |
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| Purpose of the trial |
Treatment: Other |
| Anticipated trial start date |
21/11/2017 |
| Actual trial start date |
21/11/2017 |
| Anticipated date of last follow up |
22/05/2020 |
| Actual Last follow-up date |
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| Anticipated target sample size (number of participants) |
120 |
| Actual target sample size (number of participants) |
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| Recruitment status |
Recruiting |
| Publication URL |
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