Intravitreal steroids for macular edema in people with diabetes

Macular edema, swelling of the center of the retina (the part of the eye responsible for our sharpest vision), is an important cause of poor vision in patients with diabetes. New forms of therapy are desirable because the current treatment including laser photocoagulation does not control all cases of diabetic macular edema (DME) and because laser therapy may destroy normal retinal tissue. Intraocular steroids in the form of intravitreal triamcinolone acetate injection (IVTA) and surgical implantation of fluocinolone acetonide (FAI) or dexamethasone drug delivery system (DDS) are promising new therapies. This systematic review included seven randomized clinical trials involving 632 eyes from five countries evaluating the effectiveness and safety of intravitreal steroids for treating DME. Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias, and the remaining two had an unclear risk of bias. In this systematic review, the preponderance of data suggest a beneficial effect from IVTA. The average improvement in visual acuity was 7.5 letters more (-0.15 LogMAR; 95% CI -0.21 to -0.09) in the IVTA treated eyes than in those treated with other therapies at three months (based on three trials), 11.5 letters more (-0.23 LogMAR; 95% CI -0.33 to -0.13) at six months (two trials), 14.5 letters more (-0.29 LogMAR; 95% CI -0.47 to -0.11) at nine months (one trial), and 5.7 letters more (-0.11 LogMAR; 95% CI -0.20 to -0.03) at 24 months (one trial). Improved clinical outcomes were also reported in FAI and dexamethasone DDS trials. Elevation of intraocular pressure and cataract progression occur in both IVTA and implants treated eyes but appear manageable.

Authors' conclusions: 

RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation.

Read the full abstract...
Background: 

Macular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy.

Objectives: 

This review evaluated the effectiveness and safety of intraocular steroids in treating diabetic macular edema (DME).

Search strategy: 

We searched CENTRAL, MEDLINE, EMBASE in June 2007, reference lists, Science Citation Index and conference proceedings.

Selection criteria: 

We included randomized clinical trials (RCTs) evaluating any form of intravitreal steroids for treating DME.

Data collection and analysis: 

Two authors independently assessed eligibility, methodological quality and extracted data. We performed meta-analyses when appropriate.

Main results: 

Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias.
The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial).
Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial.
Increased intraocular pressure and cataract formation were side effects requiring monitoring and management.

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