|Year : 2016 | Volume
| Issue : 1 | Page : 1-2
Update on clinical trials in retinal diseases
Vitreoretinal Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia
|Date of Web Publication||4-Jan-2016|
Vitreoretinal Division, King Khaled Eye Specialist Hospital, P.O. Box 7191, Riyadh 11462
Kingdom of Saudi Arabia
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kozak I. Update on clinical trials in retinal diseases. Middle East Afr J Ophthalmol 2016;23:1-2
Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat, or manage various diseases or medical conditions using stringent protocols. The World Health Organization definition for a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Clinical trials have been essential to the development of new interventions in ophthalmology. They are also pillars of evidence-based medicine guidelines and treatment recommendations based on the strength of scientific evidence. One such example is Scottish Intercollegiate Guidelines Network (SIGN), which makes evidence-based scientific recommendations and good clinical practice points that have specific relevance to health service infrastructure. SIGN methodology has been recently used to elaborate the preferred practice pattern ® guidelines by the American Academy of Ophthalmology for retinal vein occlusions.
Clinical trials in the field of the retina have a long tradition that continues with novel technological and pharmaceutical developments in this rapidly evolving sub-specialty of ophthalmology. The symposium on clinical trials in retinal diseases in this issue has two objectives. First, is to review the past and recent clinical trials that led to the approval of current standard of care therapies and second is to update readers on ongoing studies that may change this standard. The topics in this issue cover the most common as well as challenging retinal diseases.
Clinical trials, as we know, do bring changes to treatment paradigms. We have seen a change in the management of diabetic macular edema from macular laser photocoagulation to intravitreal anti-angiogenic injections and/or intravitreal steroid implants. Furthermore, several new agents are being investigated in level 1 evidence studies including monoclonal antibodies, interleukin 6-inhibitor, insulin-like growth factor-1 inhibitors, designed ankyrin repeat protein, or an anti-integrin oligopeptide. Similar trends toward pharmacotherapy have been observed in the management of macular edema associated with retinal vein occlusions., Monoclonal antibodies seem to be attractive investigational agents for both types of age-related macular degeneration., Ophthalmology community follows with special interest phase III trial of intravitreal lampalizumab where 936 patients are being enrolled to study the efficacy of this drug in geographic atrophy (GA). The data from a mid-stage trial showed a 20% reduction in GA lesion progression in patients treated monthly with lampalizumab as compared with sham at 18 months.
Another area of unmet need in ophthalmology is the field of retinal dystrophies. While next generation sequencing has enabled quicker and perhaps more sensitive diagnostics, the treatment options for patients are scarce and largely unsatisfactory. We currently register 17 clinical trials in gene therapy for retinal dystrophies and few in cell-based therapies. Both approaches face challenges including optimal vectors and method of delivery for the former and the source of cells, their effective transformation and implantation for the latter. With the advent of patient-specific induced pluripotent stem cells, researchers are now able to obtain disease-specific cell types that would otherwise be unavailable for molecular analysis. Finally, artificial vision restoration using epiretinal surgical implant has been studied in hope to bring some ambulatory vision to patients with severe visual impairment. The Argus ® II Retinal Prosthesis System (Second Sight Medical Products, USA) is the first prosthetic vision device to obtain regulatory approval in both Europe and the USA. Until now, over 100 devices have been implanted worldwide, representing the largest group of patients currently treated with visual prostheses.
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