Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg.
OBJECTIVE
To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema.


METHODS
Interventional case series.


METHODS



METHODS
Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation.


METHODS
Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group).


METHODS
The main outcome was central macular thickness (CMT) measured by optical coherence tomography (OCT) at four, 12, and 24 weeks. Secondary outcomes were gain in Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure (IOP), cataract progression, and duration of effect.


RESULTS
Before injection, mean (+/- SD) CMT was 564.5 +/- 119 microm and 522.9 +/- 148.5 microm in the 4- and 2-mg groups, respectively. At four, 12, and 24 weeks after injection, it was 275.0 +/- 79.8, 271.4 +/- 128.7, and 448.7 +/- 146.4 microm, respectively, in the 4-mg group, and 267.3 +/- 82.4, 289.8 +/- 111.4, and 394.7 +/- 178.9 microm, respectively, in the 2-mg group. At no time was the difference in CMT between both groups statistically significant (P> 0.3). The between-group differences in the gain in the ETDRS score and in IOP were not statistically significant either. Diabetic macular edema recurred after a median period of 20 weeks vs 16 weeks in the 4- and 2-mg groups, respectively (P = 0.11).


CONCLUSIONS
In the short term, intravitreal injection of 4 or 2 mg TA does not have different effects on CMT, visual acuity, or IOP.
Audren
François
F
Department of Ophthalmology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Université Paris, Paris, France.
Lecleire-Collet
Amélie
A
Erginay
Ali
A
Haouchine
Belkacem
B
Benosman
Rym
R
Bergmann
Jean-François
JF
Gaudric
Alain
A
Massin
Pascale
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002386:Cataract / Q000503:physiopathology; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D007429:Intraocular Pressure; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D041623:Tomography, Optical Coherence; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D014822:Vitreous Body
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide