ISIS-DME: a prospective, randomized, dose-escalation intravitreal steroid injection study for refractory diabetic macular edema.
OBJECTIVE
: To determine safety and efficacy of intravitreal triamcinolone acetonide (IVTA) for refractory clinically significant diabetic macular edema (DME).


METHODS
: Prospective, randomized, dose-escalation pilot study comparing single injection of 2 mg versus 4 mg doses of IVTA.


METHODS
: Inclusion criteria included clinically significant DME persisting >/=3 months after maximal laser treatment and visual acuity </=20/40. Best-corrected ETDRS vision, intraocular pressure, presence of DME, and fluorescein angiography (FA) were evaluated at 3 months and 6 months after injection.


RESULTS
: Mean change in visual acuity at 3 months compared to baseline was 7.1 letters (P = 0.01) in the 2 mg group and 12.5 letters in the 4 mg group (P < 0.0001). However, there was not a significant difference in visual improvement between the 2 mg and 4 mg dose groups (P = 0.11). Vision improved >15 letters at 3 months in 23% (3/13) of 2 mg group and in 33% (5/15) of 4 mg group (P = 0.69), and 0% (0/11) and 21% (3/14) at 6 months, respectively (P = 0.23). Visual improvement was more likely in cystoid-type DME than diffuse DME. Intraocular pressure rise of >/=10 mmHg occurred in 19% (3/16) of 2 mg group and 41% (7/17) of 4 mg group.


CONCLUSIONS
: Both doses of IVTA were well tolerated and had significant positive effects on refractory DME for short term. There were consistent trends throughout the study that suggest that a 4 mg IVTA may be more effective than a 2 mg dose. The benefit of IVTA was greater for cystoid-type DME.
Kim
Judy E
JE
Medical College of Wisconsin, Milwaukee, USA.
Pollack
John S
JS
Miller
David G
DG
Mittra
Robert A
RA
Spaide
Richard F
RF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D005260:Female; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure / Q000187:drug effects; D008269:Macular Edema / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage*; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide