Original article
Intravitreal Triamcinolone Acetonide for Diffuse Diabetic Macular Edema: Phase 2 Trial Comparing 4 mg vs 2 mg

https://doi.org/10.1016/j.ajo.2006.06.011Get rights and content

Purpose

To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema.

Design

Interventional case series.

Methods

patients: Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation. intervention: Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group). main outcome measures: 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 μm and 522.9 ± 148.5 μm 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 μm, respectively, in the 4-mg group, and 267.3 ± 82.4, 289.8 ± 111.4, and 394.7 ± 178.9 μm, 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.

Section snippets

Methods

This study was an interventional case series. The protocol was approved by the Institutional Review Board of the Hôpital Saint-Louis (Paris, France).

Patients were included if biomicroscopy revealed diffuse DME, if they were unresponsive to laser photocoagulation despite previous maximal focal and grid laser, and if they had no signs of vitreomacular traction or epiretinal membrane on either biomicroscopy or OCT examination. On biomicroscopy, diffuse macular edema was defined by macular

Results

Between January 2002 and September 2004, 35 patients fulfilled the inclusion criteria and agreed to participate in the study. Three were excluded because of an IOP increase exceeding 15 mm Hg after one month of treatment with topical dexamethasone 0.1%.

Thirty-two patients (32 eyes) were therefore included, and all except two completed the scheduled follow-up: one patient in the 4 mg group developed central venous occlusion that required laser photocoagulation after the 12-week follow-up visit,

Discussion

Intravitreal injection of 4 mg TA has been reported to have a dramatic effect on DME.2, 3, 4, 5, 6, 7 The aim of the present study was to find out whether a lower dose of 2 mg TA could be as effective as 4 mg and have fewer side effects.

We observed a dramatic decrease in CMT after intravitreal injection of both doses, with mean decreases in thickening of 73% and 69% at three months in the 4- and 2-mg groups, respectively. The between-group difference in the change in thickening was not

François Audren, MD, obtained his degree at the Rennes Medical School (France) in 1998 and his MD degree in Paris, France in 2003. He graduated in 2002 with a master of Experimental and Clinical Pharmacology. Since 2004, Dr Audren has held a fellowship Doctor Caputo’s in the Department of Pediatric Ophthalmology at the Rosthchild Foundation in Paris. Dr Audren’s research interests are in triamcinolone treatment of diabetic macular edema; his clinical interests are in the area of pediatric

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François Audren, MD, obtained his degree at the Rennes Medical School (France) in 1998 and his MD degree in Paris, France in 2003. He graduated in 2002 with a master of Experimental and Clinical Pharmacology. Since 2004, Dr Audren has held a fellowship Doctor Caputo’s in the Department of Pediatric Ophthalmology at the Rosthchild Foundation in Paris. Dr Audren’s research interests are in triamcinolone treatment of diabetic macular edema; his clinical interests are in the area of pediatric ophthalmology, strabismus, and neuroophthalmology.

Pascale Massin, MD, PhD, went to Pitié-Salpétrière, Paris University 6 where she obtained her Medical Degree, Paris, France. Dr Massin did her Resident in Ophthalmology, Assistance Publique at Paris University, Paris France and her fellowship at the Ophthalmology department of the Hôpital Lariboisière, Paris University 7, Paris, France. Dr Massin’s interest includes medical and surgical retina, especially macular surgery and diabetic retinopathy. Evaluation and treatment of diabetic macular edema; macular dystrophies associated to mitochondrial diabetes, screening for diabetic retinopathy using telemedicine.

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