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Clinical Trial
. 2015 Oct 30:15:150.
doi: 10.1186/s12886-015-0148-2.

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study

Albert J Augustin  1 , Baruch D Kuppermann  2 , Paolo Lanzetta  3 , Anat Loewenstein  4 , Xiao-Yan Li  5 , Harry Cui  6 , Yehia Hashad  7 , Scott M Whitcup  8 ; Ozurdex MEAD Study Group
Affiliations
Clinical Trial

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study

Albert J Augustin et al. BMC Ophthalmol. .

Abstract

Background: Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME.

Methods: Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34-68 Early Treatment Diabetic Retinopathy Study letters (20/200-20/50 Snellen equivalent), and central retinal thickness (CRT) ≥ 300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥ 15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry.

Results: Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5% of DEX 0.7 patients versus 11.1 % of sham had ≥ 15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was -126.1 μm with DEX 0.7 versus -39.0 μm with sham (P < .001). Cataract-related adverse events were reported in 70.3% of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery.

Conclusions: DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, intravitreal anti-vascular endothelial growth factor, intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population.

Trial registration: ClinicalTrials.gov NCT00168337 and NCT00168389, registered 12 September 2005.

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Figures

Fig. 1
Fig. 1
Survival analysis of the time to ≥15-letter improvement in best-corrected visual acuity (BCVA) from baseline. *P < 0.001 vs sham (log-rank test comparing cumulative response rate curves over time). DEX 0.7 = dexamethasone intravitreal implant 0.7 mg
Fig. 2
Fig. 2
Mean average best-corrected visual acuity (BCVA) change from baseline before and after cataract surgery. Results are shown for previously treated patients with cataract-related adverse events (AEs) in the dexamethasone intravitreal implant 0.7 mg group. Numbers in parentheses indicate number of patients
See this image and copyright information in PMC

References

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