Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
To investigate the role of ranibizumab and angiographically-directed peripheral scatter laser
therapy in patients with clinically-significant diabetic macular edema (CSME) and peripheral
nonperfusion. We propose a novel treatment of CSME in a subgroup of patients defined by a
combination of ultrawide-field angiography (UWFA) and optical coherence tomography (OCT).
Within this classification scheme, patients with CSME are subdivided by the presence of: 1)
focal macular leakage, 2) vitreomacular interface traction, and/or 3) peripheral
nonperfusion. The successful treatment of diabetic macular edema would be dictated by
pathophysiology-directed therapy based on this classification.
The subgroup of interest for this clinical trial is characterized by diabetic macular edema,
peripheral nonperfusion on UWFA, and the absence of macular traction on OCT. This group of
patients has previously not been well recognized or characterized due to limitations in
previous, standard angiographic evaluation of the retinal periphery.
We postulate that this subcategory represents one with a high rate of failure of accepted
therapies given persistence of the basic pathophysiologic mechanism for CSME, namely
ischemia-induced production of Vascular Endothelial Growth Factor (VEGF) from the retinal
periphery. This also represents a population of patients with likely recurrence of CSME
despite treatment with anti-VEGF therapy alone for the same reason.