Randomized trial of peribulbar triamcinolone acetonide with and without focal photocoagulation for mild diabetic macular edema: a pilot study.
OBJECTIVE
To provide pilot data on the safety and efficacy of anterior and posterior sub-Tenon injections of triamcinolone either alone or in combination with focal photocoagulation in the treatment of mild diabetic macular edema (DME).


METHODS
Prospective, phase II, multicenter, randomized clinical trial.


METHODS
One hundred nine patients (129 eyes) with mild DME and visual acuity 20/40 or better.


METHODS
The participants were assigned randomly to receive either focal photocoagulation (n = 38), a 20-mg anterior sub-Tenon injection of triamcinolone (n = 23), a 20-mg anterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 25), a 40-mg posterior sub-Tenon injection of triamcinolone (n = 21), or a 40-mg posterior sub-Tenon injection followed by focal photocoagulation after 4 weeks (n = 22). Follow-up visits were performed at 4, 8, 17, and 34 weeks.


METHODS
Change in visual acuity and retinal thickness measured with optical coherence tomography (OCT).


RESULTS
At baseline, mean visual acuity in the study eyes was 20/25 and mean OCT central subfield thickness was 328 mum. Changes in retinal thickening and in visual acuity were not significantly different among the 5 groups at 34 weeks (P = 0.46 and P = 0.94, respectively). There was a suggestion of a greater proportion of eyes having a central subfield thickness less than 250 mum at 17 weeks when the peribulbar triamcinolone was combined with focal photocoagulation. Elevated intraocular pressure and ptosis were adverse effects attributable to the injections.


CONCLUSIONS
In cases of DME with good visual acuity, peribulbar triamcinolone, with or without focal photocoagulation, is unlikely to be of substantial benefit. Based on these results, a phase III trial to evaluate the benefit of these treatments for mild DME is not warranted.
Chew
E
E
Strauber
S
S
Beck
R
R
Aiello
L P
LP
Antoszyk
A
A
Bressler
N
N
Browning
D
D
Danis
R
R
Fan
J
J
Flaxel
C
C
Friedman
S
S
Glassman
A
A
Kollman
C
C
Lazarus
H
H
D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007267:Injections; D017075:Laser Coagulation / Q000009:adverse effects / Q000379:methods*; D008269:Macular Edema / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009915:Orbit; D010865:Pilot Projects; D011446:Prospective Studies; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide