Intravitreal plasmin without associated vitrectomy as a treatment for refractory diabetic macular edema.
OBJECTIVE
To determine the effectiveness of a low-dose intravitreal injection of autologous plasmin enzyme (APE), without the performance of a vitrectomy, as a treatment for refractory diffuse diabetic macular edema (DDME).


METHODS
Prospective, comparative, interventional case series.


METHODS
Sixteen patients with bilateral DDME who had not responded to prior laser photocoagulation. All patients received an injection in 1 eye, while the other eye served as a control.


METHODS
Intravitreal 0.2 mL APE injection under topical anesthesia. The APE was obtained using a simplified method.


METHODS
Central macular thickness (CMT) at 1 and 6 months, determined by optical coherence tomography (OCT) and best corrected visual acuity (BCVA).


RESULTS
All patients underwent a 1-month follow-up. Prior to injection, CMT in the eye about to receive the injection was 541 +/- 79 microm (mean +/- standard deviation [SD]) versus 535 +/- 76 microm in the control eye. One month after injection, CMT was 241 +/- 47 microm in injected eyes and 530 +/- 85 microm in control eyes (P < 0.001, bilateral Wilcoxon test for paired samples). The macular edema (ME) improved in all injected eyes (100%), with complete resolution in 7 patients (44%). The mean BCVA of treated eyes was 0.618 +/- 0.27 (mean +/- SD) at baseline and 0.45 +/- 0.24 four weeks after injection (paired samples t-test, P < 0.001). No adverse effects were observed in any of the patients. BCVA and CMT were stable when evaluated at 6-month follow-up (0.43 +/- 0.242 and 244 +/- 46 microm, respectively).


CONCLUSIONS
Intravitreal APE injection effectively reduces macular thickening due to DDME in cases that fail to respond to conventional laser photocoagulation, and improves visual acuity in a short term, and this results remain stable in a medium term what is very important. Further investigation is warranted in order to assess long-term efficacy and safety.
Diaz-Llopis
Manuel
M
Department of Ophthalmology, Hospital General, Valencia, Spain.
Udaondo
Patricia
P
Arevalo
Fernando
F
Salom
David
D
Garcia-Delpech
Salvador
S
Quijada
Arturo
A
Romero
Francisco Javier
FJ
D000368:Aged; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005341:Fibrinolysin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D017075:Laser Coagulation / Q000379:methods; D008269:Macular Edema / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D041623:Tomography, Optical Coherence / Q000379:methods; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body / Q000378:metabolism
D005343:Fibrinolytic Agents; D005341:Fibrinolysin