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Updates on the Clinical Trials in Diabetic Macular Edema.

Demirel S, Argo C, Agarwal A, Parriott J, Sepah YJ, Do DV, Nguyen QD - Middle East Afr J Ophthalmol (2016 Jan-Mar)

Bottom Line: In this era of evidence-based medicine, significant progress has been made in the field of pharmacotherapeutics for the management of diabetic macular edema (DME).However, due to a number of challenges in the management of DME with approved agents, further studies are needed.For the purpose of this review, an extensive database search in English language was performed to identify prospective, RCTs testing pharmacological agents for DME.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Faculty of Medicine, Ankara University, Ankara, Turkey; University of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Omaha, Nebraska, USA.

ABSTRACT
In this era of evidence-based medicine, significant progress has been made in the field of pharmacotherapeutics for the management of diabetic macular edema (DME). A. number of landmark clinical trials have provided strong evidence of the safety and efficacy of agents such as anti-vascular endothelial growth factors for the treatment of DME. Decades of clinical research, ranging from the early treatment of diabetic retinopathy study to the present-day randomized clinical trials (RCTs) testing novel agents, have shifted the goal of therapy from preventing vision loss to ensuring a maximum visual gain. Systematic study designs have provided robust data with an attempt to optimize the treatment regimens including the choice of the agent and timing of therapy. However, due to a number of challenges in the management of DME with approved agents, further studies are needed. For the purpose of this review, an extensive database search in English language was performed to identify prospective, RCTs testing pharmacological agents for DME. In order to acquaint the reader with the most relevant data from these clinical trials, this review focuses on pharmacological agents that are currently approved or have widespread applications in the management of DME. An update on clinical trials presently underway for DME has also been provided.

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Related in: MedlinePlus

Timeline of major milestones in the field of pharmacotherapeutics for diabetic macular edema. In the figure, a number of landmark randomized clinical trials that have brought a paradigm change in the management of diabetic macular edema and led to the approval of therapeutic agents have been chronicled (based on the publication dates of the primary outcome manuscript in MEDLINE®, United States National Library of Medicine)
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Figure 1: Timeline of major milestones in the field of pharmacotherapeutics for diabetic macular edema. In the figure, a number of landmark randomized clinical trials that have brought a paradigm change in the management of diabetic macular edema and led to the approval of therapeutic agents have been chronicled (based on the publication dates of the primary outcome manuscript in MEDLINE®, United States National Library of Medicine)

Mentions: The ETDRS established focal/grid laser as a standard of care for DME.131718 However, a significant number of patients treated with a laser would continue to lose vision leading to suboptimal treatment outcomes.1518 Furthermore, results from recent studies employing microperimetry to assess retinal function suggest that laser therapy may be associated with worsening of macular function that is not detectable with routine BCVA testing.19 These results have led to the development of new therapeutic approaches based on our increasing understanding of the pathogenesis of DME [Figure 1]. Depicts the timeline of events in the development of newer therapeutic strategies for DME.


Updates on the Clinical Trials in Diabetic Macular Edema.

Demirel S, Argo C, Agarwal A, Parriott J, Sepah YJ, Do DV, Nguyen QD - Middle East Afr J Ophthalmol (2016 Jan-Mar)

Timeline of major milestones in the field of pharmacotherapeutics for diabetic macular edema. In the figure, a number of landmark randomized clinical trials that have brought a paradigm change in the management of diabetic macular edema and led to the approval of therapeutic agents have been chronicled (based on the publication dates of the primary outcome manuscript in MEDLINE®, United States National Library of Medicine)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4759901&req=5

Figure 1: Timeline of major milestones in the field of pharmacotherapeutics for diabetic macular edema. In the figure, a number of landmark randomized clinical trials that have brought a paradigm change in the management of diabetic macular edema and led to the approval of therapeutic agents have been chronicled (based on the publication dates of the primary outcome manuscript in MEDLINE®, United States National Library of Medicine)
Mentions: The ETDRS established focal/grid laser as a standard of care for DME.131718 However, a significant number of patients treated with a laser would continue to lose vision leading to suboptimal treatment outcomes.1518 Furthermore, results from recent studies employing microperimetry to assess retinal function suggest that laser therapy may be associated with worsening of macular function that is not detectable with routine BCVA testing.19 These results have led to the development of new therapeutic approaches based on our increasing understanding of the pathogenesis of DME [Figure 1]. Depicts the timeline of events in the development of newer therapeutic strategies for DME.

Bottom Line: In this era of evidence-based medicine, significant progress has been made in the field of pharmacotherapeutics for the management of diabetic macular edema (DME).However, due to a number of challenges in the management of DME with approved agents, further studies are needed.For the purpose of this review, an extensive database search in English language was performed to identify prospective, RCTs testing pharmacological agents for DME.

View Article: PubMed Central - PubMed

Affiliation: Department of Ophthalmology, Faculty of Medicine, Ankara University, Ankara, Turkey; University of Nebraska Medical Center, Stanley M. Truhlsen Eye Institute, Omaha, Nebraska, USA.

ABSTRACT
In this era of evidence-based medicine, significant progress has been made in the field of pharmacotherapeutics for the management of diabetic macular edema (DME). A. number of landmark clinical trials have provided strong evidence of the safety and efficacy of agents such as anti-vascular endothelial growth factors for the treatment of DME. Decades of clinical research, ranging from the early treatment of diabetic retinopathy study to the present-day randomized clinical trials (RCTs) testing novel agents, have shifted the goal of therapy from preventing vision loss to ensuring a maximum visual gain. Systematic study designs have provided robust data with an attempt to optimize the treatment regimens including the choice of the agent and timing of therapy. However, due to a number of challenges in the management of DME with approved agents, further studies are needed. For the purpose of this review, an extensive database search in English language was performed to identify prospective, RCTs testing pharmacological agents for DME. In order to acquaint the reader with the most relevant data from these clinical trials, this review focuses on pharmacological agents that are currently approved or have widespread applications in the management of DME. An update on clinical trials presently underway for DME has also been provided.

Show MeSH
Related in: MedlinePlus