Volume 20, Number 15Monday, April 6, 2020APRIL IS SPORTS EYE SAFETY MONTH In this issue: (click heading to view article)
Safety & Efficacy of Brimonidine Drug Delivery System in GA Secondary to AMDResearchers evaluated the safety and efficacy of the Brimonidine Drug Delivery System (Brimo DDS), a biodegradable intravitreal implant, in the treatment of geographic atrophy secondary to age-related macular degeneration, as part of a Phase II, randomized, multicenter, double-masked, 24-month study.Study eyes were treated on day one, and then with a retreatment at month six, with Brimo DDS 132 µg (n=49), Brimo DDS 264 µg (n=41) or sham procedure (n=23). The primary timepoint for efficacy analysis was month 12. Here were some of the findings: • Mean GA area growth at month 12 was 1.78 mm2 in the Brimo DDS 132 µg, 1.59 mm2 in the Brimo DDS 264 µg group, and 2.19 mm2 in the sham group. • Geographic atrophy area growth was consistently smaller with Brimo DDS 132 and 264 µg than the sham group; between-group differences were significant (p≤0.032) at month three. • In patients with baseline lesion area ≥6 mm2 (two-thirds of patients), GA lesion area and effective radius growth was reduced with Brimo DDS 132 and 264 µg at month 12 (p≤ 0.050 vs. sham). • Treatment-related adverse events were usually injection procedure-related. Researchers found that Brimo DDS demonstrated a favorable safety profile and reduced GA lesion area growth at month three. They reported that lesion growth at month 12 was reduced in individuals with baseline GA lesion area ≥6 mm2. They say the results support Phase III development. SOURCE: Kuppermann BD, Patel SS, Boyer DS, et al. Phase 2 study of the safety and efficacy of brimonidine drug delivery system (Brimo DDS) generation 1 in patients with geographic atrophy secondary to age-related macular degeneration. Retina 2020; Mar 3. [Epub ahead of print]. Keratoconus Prognosis Regarding Corneal External Mechanical StressInvestigators aimed to demonstrate the correlation between excessive eye rubbing and corneal degeneration for keratoconus patients. Source: Bettahar T, Rahmoune C, Benazzouz D, et al. Keratoconus prognosis study for patients with corneal external mechanical stress mode. Int Ophthalmol 2020; Mar 26. [Epub ahead of print.] Using OCTA to Measure Diurnal Vessel Density Variations in Glaucoma & OHTScientists evaluated diurnal variations in optic nerve head vessel density assessed by optical coherence tomography angiography in healthy subjects, and ocular hypertension and open-angle glaucoma patients.Forty subjects (OAG: 21; OHT: six; healthy: 13) were assessed for vessel density (VD) percentage and flow index in the ONH (NH VD percentage, NH index), and in the radial peripapillary capillary layer (RPC VD percentage, RPC index) at 9:00, 11:00, 14:00, 16:00 and 18:00 on a single day. Repeated analyses of variance were used to test for changes in the parameters measured at multiple time points. Here were some of the findings: • All OCTA parameters analyzed at the different time points were statistically lower in the OAG patients compared with OHT and healthy groups (p<0.05). • In the OAG group, the NH index, RPC index, and NH VD and RPC VD percentages were statistically lower at 18:00 compared with 14:00, and the RPC VD percentage was statistically lower at 9:00 than 14:00. • In the OHT group, the RPC index was statistically lower at 9:00 than 11:00. • In the healthy group, the NH VD percentage and RPC VD percentage were statistically lower at 16:00 than 18:00, and the RPC index was statistically lower at 9:00 than 11:00. • No other statistically significant difference was found in the three groups comparing any other time point (p>0.05). Scientists noted that in healthy subjects, and OHT and OAG patients, variations in OCTA-derived parameters were relatively small. They wrote that these results suggest that in clinical practice, OCTA assessment could be performed independently of the time of the day, contrasted with IOP evaluation. SOURCE: Verticchio Vercellin AC, Harris A, Tanga L, et al. Optic nerve head diurnal vessel density variations in glaucoma and ocular hypertension measured by optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol 2020; Mar 27. [Epub ahead of print]. Five-Year Outcomes After Initial Aflibercept, Bevacizumab or Ranibizumab Treatment for DMEResearchers assessed follow-up treatment and clinical outcomes at five years in eyes initially treated with anti-VEGF therapy for center involved diabetic macular edema (CI-DME) in a two-year randomized clinical trial, as part of a multicenter cohort study.Participants included individuals with DME and visual acuity of 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits five years after randomization (three years after Protocol T completion). Individuals were assigned randomly to aflibercept, bevacizumab or ranibizumab with protocol-defined follow-up and retreatment for two years. Thereafter, participants were managed at clinician discretion and recalled for a five-year visit. Main outcome measures included anti-VEGF treatment, VA letter score and central subfield thickness. Sixty-eight percent (317 of 463) of eligible participants completed the five-year visit. Here were some of the findings: • Between years two and five, 68 percent (217 of 317) of study eyes received at least one anti-VEGF treatment (median [interquartile range] 4 [0, 12]). • At five years, mean VA improved from baseline by 7.4 letters (CI, 5.9 to 9), but decreased by 4.7 letters (CI, 3.3 to 6.0) between two and five years. • When baseline VA was 20/50 to 20/320, mean five-year VA was 11.9 letters (CI, 9.3 to 14.5) better than baseline, but 4.8 letters (CI, 2.5 to 7) worse than at two years. • When baseline VA was 20/32 to 20/40, mean five-year VA was 3.2 letters (CI, 1.4 to 5) better than baseline, but 4.6 letters (CI, 3.1 to 6.1) worse than at two years. • Mean central subfield thickness decreased from baseline to five years by 154 μm (CI, 142 to 166), and was stable between two and five years (-1 μm [CI, -12 to 9]). Researchers reported that, among the two-thirds of eligible Protocol T participants who completed a five-year visit, mean VA improved from baseline to five years without protocol-defined treatment after follow-up ended at two years. Although mean retinal thickness was similar at two and five years, mean VA worsened during this period. Researchers wrote that additional investigation into strategies to improve long-term outcomes in eyes with DME was warranted to determine if VA could be better maintained with different management approaches. SOURCE: Glassman AR, Wells III JA, Josic K, et al. Five-year outcomes after initial aflibercept, bevacizumab, or ranibizumab treatment for diabetic macular edema (protocol t extension study). Ophthalmology 2020; March 28. [Epub ahead of print]. 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