Treatment of nonproliferative diabetic retinopathy with Defibrotide in noninsulin-dependent diabetes mellitus: a pilot study.
OBJECTIVE
Microvascular alterations, impairment of coagulation, ischemia and diffuse endothelial damage are related to the progression of diabetic retinopathy. Defibrotide has been demonstrated to produce profibrinolytic, cytoprotective and vasofacilatory activities. The aim of the present study was to evaluate the therapeutic effect of Defibrotide in the treatment of nonproliferative diabetic retinopathy.


METHODS
Two randomized age- and sex-matched groups (cases and controls) of 35 NIDDM patients presenting non-proliferative diabetic retinopathy were included in this study: cases were treated with Defibrotide (800-1600 mg daily) for two years.


RESULTS
All tested parameters (ETDRS visual acuity; computerized perimetry; retinography; fluorescein angiography), improved significantly (p<0.001) in Defibrotide-treated patients compared to controls. In our opinion, Defibrotide's manifold effects on vascular endothelia may account for this improvement by stimulation of tPA, PGI2, PGE2, thrombomodulin and modulation of endothelin-1 release.


CONCLUSIONS
Our preliminary data seem to suggest that Defibrotide could be proposed for medical treatment of nonproliferative diabetic retinopathy.
Vingolo
E M
EM
University of Rome La Sapienza, Italy.
De Mattia
G
G
Giusti
C
C
Forte
R
R
Laurenti
O
O
Pannarale
M R
MR
D000368:Aged; D016022:Case-Control Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications*; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D015232:Dinoprostone / Q000097:blood; D019332:Endothelin-1 / Q000097:blood; D004730:Endothelium, Vascular / Q000187:drug effects / Q000378:metabolism / Q000473:pathology; D011464:Epoprostenol / Q000097:blood; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011089:Polydeoxyribonucleotides / Q000627:therapeutic use*; D012160:Retina / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D018180:Thrombomodulin / Q000097:blood / Q000187:drug effects; D010959:Tissue Plasminogen Activator / Q000097:blood / Q000187:drug effects; D016896:Treatment Outcome; D058609:Visual Field Tests
D019332:Endothelin-1; D005343:Fibrinolytic Agents; D011089:Polydeoxyribonucleotides; D018180:Thrombomodulin; C036901:defibrotide; D011464:Epoprostenol; D010959:Tissue Plasminogen Activator; D015232:Dinoprostone