Eric Parrat

Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema

Purpose: To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex®) in diabetic macular edema (DME). Methods: This was a retrospective multicenter noncomparative study. Seventy-eight patients with DME followed for at least 6 months were included (P1.5 Network). Best-corrected visual acuity (BCVA), central retinal thickness (CRT), intraocular pressure (IOP) and cataract progression were studied at baseline and then at 1, 2, 4 and 6 months. Results: The mean CRT decrease from baseline was 145.2 µm at 6 months. The mean BCVA improvement from baseline was 6.7 at 6 months. An increase in IOP was observed for 11.7% of patients, and all patients were managed by topical treatment. No glaucoma or cataract surgery was necessary, and no endophthalmitis was reported. Conclusions: One injection of Ozurdex has an anatomical and functional effectiveness for the treatment of DME. Side effects were rare and manageable in our practice.

Ozurdex in the management of the macular edema following retinal vein occlusion in clinical practice

when the primary tumour was diagnosed, a higher percentage than that was reported from Collaborative Ocular Melanoma Study (COMS) of <1% frequency (Diener-West et al. 2001). This may arise from selection bias, because our hospital is a tertiary referral centre, or from racial and ethnic disparity. All patients with metastasis died at a median of 5.0 months (range, 1–12) after detection of dissemination. The survival rate at 3 and 5 years after enucleation was 68% (95% confidence interval [CI], 48–88) and 53% (95% CI, 32–74), respectively (Fig. 1A). The rate 6 months after detection of metastasis was 31% (95% CI, 6–56; Fig. 1B). All three patients with ciliary body melanoma developed metastasis. Liver was the most common site of metastasis (12 ⁄12), followed by bone (5 ⁄12), lung (2 ⁄12), lymph nodes and brain (each 1 ⁄12). After detection of metastasis, three patients with a single site of metastasis survived 1, 6 and 10 months. Nine patients with two or more sites of metastases survived a median of 5 months (range, 3–12; p = 0.32). The 5-year survival rates for the four size categories T1–T4 were 100%, 75% (95% CI, 54–96), 31% (95% CI, 14– 48) and 26% (95% CI, 5–57), respectively (Fig. 1C), based on the American Joint Committee on Cancer (AJCC) tumour, node, metastasis (TNM 7th edition) criteria (AJCC 2010). The 5year survival rates for the four stages IIV were 100%, 56% (95% CI, 39–73), 42% (95% CI, 20–64) and 0%, respectively (Fig. 1D). These rates are lower than is given for the large material used to develop the TNM classification (AJCC 2010), partly because three patients had metastasis at diagnosis. Larger tumour size and non-spindle cell melanoma (epithelioid or mixed cell melanoma) were associated with shorter survival (log-rank test; p = 0.02 and p < 0.01). The 5-year survival rates for spindle and non-spindle cell melanoma (epithelioid or mixed cell melanoma) were 100% and 34% (Fig. 1E; 95% CI, 21–47). Age, gender and extraocular extension were not associated with survival in this small series (Table 1).

Long-term efficacy and safety of intravitreal dexamethasone implant for the treatment of diabetic macular edema.

Purpose To evaluate the long-term efficacy and safety of the dexamethasone intravitreal implant Ozurdex® in the treatment of diabetic macular edema (DME). Methods This was a retrospective noncomparative study. A total of 23 patients with DME followed for at least 12 months were included. All patients were treated with at least 2 Ozurdex® injections for the treatment of DME. Best-corrected visual acuity, central retinal thickness, intraocular pressure (IOP), and cataract progression were recorded over 12 months. Results From baseline, the mean decrease in central retinal thickness was 315.9 µm at the 12th month and the mean best-corrected visual acuity improvement from baseline was 8.7 letters. Ozurdex® is administered via the extended release system Novadur®. Its efficacy extends beyond 4 months with a single injection and permits allows good stabilization until the 12th month, with 2.13 injections during this period. An increase in IOP was observed in 13.1% of patients and all were managed using topical IOP-lowering medications. No glaucoma or cataract surgery was necessary, and no endophthalmitis was reported. Conclusions In real-life clinical practice, Ozurdex® has anatomical and functional effectiveness for the treatment of DME. Side effects were rare and manageable in our practice.

Long-Term Real-Life Efficacy and Safety of Repeated Ozurdex® Injections and Factors Associated with Macular Edema Resolution after Retinal Vein Occlusion: The REMIDO 2 Study

Purpose: The objective was to study long-term real-life efficacy and safety of repeated Ozurdex® injections and factors associated with macular edema (ME) resolution after retinal vein occlusion. Methods: Patients with ME after retinal vein occlusion, receiving Ozurdex®, were included to assess the following endpoints: visual acuity and central retinal thickness, retreatment, number of injections, side effects and ME resolution. ME resolution was defined as permanent discontinuation of intravitreal injections (IVTs) for at least 6 months after the last IVT. Results: A total of 94 eyes were included with an average of 2.6 IVTs (max 6 IVTs). 58.6% of patients gained ≥15 letters and 51.1% of patients showed ME resolution. Among the resolved patients, 64.6% were treatment-naïve, 60.4% had branch retinal vein occlusion, and 78.1% gained ≥15 letters. Conclusions: Ozurdex® seemed to be a valuable treatment which may allow to achieve long-term anatomical and functional improvements and ME resolution with a minimum number of IVTs.

Dexamethasone Implants in Patients with Naive Diabetic Macular Edema

patient population, which could have influenced the investigation in the context of patient responses as well as of outcome measures. These findings suggest that some baseline characteristics of patients could affect the results obtained. Aknin et al. [1] enrolled 48% of treatment-naive patients, and 76% were naive to any previous antivascular endothelial growth factor injections. Likewise, Escobar-Barranco et al. [6] reported values significantly better in the naive group, while central retinal thickness decreased significantly and similarly in both groups (naive and non-naive patients). Thus, these data support the notion that treatment-naive patients present better reDear Editor We have read the comments of Aknin et al. [1] on our article entitled ‘Efficacy and safety of intravitreal dexamethasone implant in patients with diabetic macular edema’ [2] with great interest. Aknin et al. [1] present a long-term follow-up study of patients with diabetic macular edema (DME) treated with Ozurdex ® . The authors report a significant improvement in the best corrected visual acuity, with a mean gain of at least 13 letters during the follow-up period and similar positive results on central retinal thickness. These results are better than those reported in our study [2] and many previous studies [3–5] . We think that these differences could be due to the baseline characteristics of the Received: March 3, 2016 Accepted: April 14, 2016 Published online: May 14, 2016