To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME). Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis. Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography. Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP). Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 μm) and DEX implant 0.35 mg (-107.9 μm) than sham (-41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy. The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome. Post hoc analysis of randomized controlled trial data. Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA). In the analysis population (340 eyes), <5-, 5- to 9-, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5-9, and ≥10 letters of improvement at 12 weeks), mean CFB BCVA at 52-156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders. Ranibizumab ± laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).

If contact lens or spectacle correction is not viable, little debate exists that the secondary placement of an intra-ocular lens (IOL) is the method of choice in the absence of capsular support. The choice of IOL mainly depends on the preoperative status of the eye (eg, aphakia in children) and the selected location for the implant. Theoretically, there are several IOL implantation approaches in cases without capsular support: an angle-supported anterior chamber (AC) IOL, an iris-fixated ACIOL, an iris-sutured or iris-fixated posterior chamber (PC) IOL and a transsclerally sutured PCIOL. No consensus exists, however, on the indications as well as on the relative safety and efficacy of these different options. Implantation of modern ACIOLs, like the refined open-loop or iris-fixated claw (toric) ACIOLs, have regained popularity and provide a valuable alternative to sutured PCIOLs. However, in the absence of capsular support, the transsclerally sutured PCIOLs offer numerous advantages for certain eyes. Because of its anatomic location, the sutured PCIOL is more appropriate for eyes with compromised cornea, peripheral anterior synechiae, shallow anterior chamber, or glaucoma. Moreover, sutured PCIOLs are appropriate if the patient with aphakia is young or has a life expectancy of 10 years or more. Recent technological advances, including PCIOL with iris diaphragm for aniridia, toric ACIOLs, and small-incision surgery with foldable, transsclerally sutured IOLs, seem to further improve clinical outcomes.

To evaluate the efficacy and safety of triple therapy with verteporfin photodynamic therapy (PDT), dexamethasone, and bevacizumab in choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). This prospective, noncomparative, interventional case series included 104 patients. Verteporfin PDT was administered with a reduced light dose (42 J/cm2, accomplished by light delivery time of 70 seconds). Approximately 16 hours after PDT, dexamethasone (800 μg) and bevacizumab (1.5 mg) were injected intravitreally. Patients attended follow-up visits every 6 weeks, undergoing visual acuity and intraocular pressure measurement, slit-lamp and ophthalmoscopic examination, and optical coherence tomography (OCT). Fluorescein angiography was performed every 3 months or earlier if OCT showed significant edema. All 104 patients received one triple therapy cycle (5 patients received a second triple treatment due to remaining CNV activity). The triple therapy was complemented in 18 patients (17.3%) by an additional intravitreal injection of bevacizumab. The mean follow-up period was 40 weeks (range, 22–60 weeks). Mean increase in visual acuity was 1.8 lines (P < 0.01). Mean decrease in retinal thickness was 182 μm (P < 0.01). No serious adverse events have been observed. In most patients with CNV due to AMD, triple therapy results in significant and sustained visual acuity improvement after only one cycle of treatment. In addition, the therapy offers a good safety profile, potentially lower cost compared with therapies that must be administered more frequently, and convenience for patients.