Cutting Edge Glaucoma - Issue 2

TWO-YEAR RESULTS OF A MULTICENTER STUDY OF THE AB INTERNO GELATIN IMPLANT IN MEDICALLY... • 35  clinical hypotony-related complications (such as flat anterior chamber with iridocorneal touch extending to the pupil, hypotony maculopathy, and choroidal effusion lasting > 30 days [requir- ing surgical intervention]), retinal detachment, vitreous hemorrhage, or any other AE causing permanent visual impairment. Fig. 4: Kaplan-Meier curve showing the probability of achieving success criteria at months 12 and 24 (mITT population). Failures were due to glaucoma-related secondary surgical intervention (SSI—which did not in- clude needling) during the study period, or IOP reduction < 20% on the same number of medications or fewer at 12 and 24 months. Right censoring assumption was used. Probability of success was 67% at month 12 and 58% at month 24. Note: eyes that did not undergo SSI but failed to meet success criteria at month 12 were deemed to have failed, even if they met the success criteria at month 24. Tick signs indicate censored times, corresponding to incidences when eyes discontinued early or completed the study without experiencing any failures. IOP , intraocular pressure; mITT , modified intent-to-treat Fig. 3: Percentage of eyes with available data achieving success in the mITT population at months 12 and 24. Success was defined by eyes achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention (SSI) or intention to be converted to another proce- dure. mITT , modified intent-to-treat; phaco , phacoemulsification with intraocular lens replacement ract aggravated, retinal disorder (central retinal vein lusion reported at 12 months, without elevated IOP), junctival erosion (implant exposure), glaucoma-related (due to hospitalization for surgery), endophthalmitis orted 15 months after implantation — detail provided able 6 ), and high IOP with SSI (cyclodestructive pro- ure) in the untreated fellow eye ( n = 1 each; Table 6 ). e patient had both systemic and ocular SAEs. ot unexpectedly, mean best-corrected visual acuity (SD, MAR) improvements from baseline at 12 and 24 months e noted in the phaco + implant group ( − 0.27 [0.24] and .23 [0.24]), compared with the implant alone group ( − 0.02 9] and 0.01 [0.21]), respectively. Changes in mean central neal thickness (SD) were not statistically significant at 12 24 months. The change from baseline in average visual d mean deviation was not statistically significant at months ( − 1.0 [8.3]; P = 0.138). Discussion This prospective, 24-month, non-randomized, open-lab multicenter study conducted in typical clinical settin assessed the long-term effectiveness and safety of the gelat implant in patients with POAG uncontrolled on topical IO lowering medications. Mean IOP was reduced from 21.4 (3. (medicated baseline) to 14.9 (4.5) mmHg at month 12 a 15.2 (4.2) mmHg at month 24; the mean IOP-lowering me ication count decreased from 2.7 (0.9) at baseline to 0.9 (1. at month 12 and 1.1 (1.2) at month 24. Similar results we observed in both treatment groups at all postoperative visits to 24 months ( P > 0.4, between-group comparisons). In ad tion, no differences in outcomes were noted at 24 months pseudophakic eyes that received the implant alone, compar with the overall implant alon group and the phaco + impla group. These findings are consistent with other reports 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 Probability of clinical success Months 0.2 0.1 0.0 0 3 6 9 12 18 24 4 Kaplan-Meier curve showing the probability of achieving success ria at months 12 and 24 (mITT population). Failures were due to coma-related secondary surgical intervention (SSI — which did not ude needling) during the study period, or IOP reduction < 20% on same number of medications or fewer at 12 and 24 months. Right oring assumption was used. Probability of success was 67% at month 12 and 58% at month 24. Note: eyes that did not undergo SSI but failed meet success criteria at month 12 were deemed to have failed, even if th met the success criteria at month 24. Tick signs indicate censored tim corresponding to incidences when eyes discontinued early or complet the study without experiencing any failures. IOP, intraocular pressur mITT, modified intent-to-treat lation at months 12 and 24. Success was defined by eyes achieving ≥ IOP reduction from baseline on the same or fewer medications without converted to another procedure. mITT, modified intent-to-treat; phac phacoemulsification with intraocular lens replacement ct aggravated, retinal disorder (central retinal vein ion reported at 12 months, without elevated IOP), nctival erosion (implant exposure), glaucoma-related ue to hospitalization for surgery), endophthalmitis ted 15 months after implantation — detail provided le 6 ), and high IOP with SSI (cyclodestructive pro- e) in the untreated fellow eye ( n = 1 each; Table 6 ). atient had both systemic and ocular SAEs. t unexpectedly, mean best-corrected visual acuity (SD, R) improvements from baseline at 12 and 24 months noted in the phaco + implant group ( − 0.27 [0.24] and [0.24]), compared with the implant alone group ( − 0.02 and 0.01 [0.21]), respectively. Changes in mean central l thickness (SD) were not statistically significant at 12 4 onths. The change from bas lin in average visual m an deviation was not statistically sig ificant at nths ( − 1.0 [ .3]; P = 0.138). Discussion This prospective, 24-month, non-randomized, ope multicenter study conducted in typical clinical assessed the long-term effectiveness and safety of the implant in patients with POAG uncontrolled on topi lowering medications. Mean IOP was reduced from 2 (medicated baseline) to 14.9 (4.5) mmHg at month 15.2 (4.2) mmHg at month 24; the mean IOP-loweri ication count decreased from 2.7 (0.9) at baseline to at month 12 and 1.1 (1.2) at month 24. Similar resu observed in both treatment groups at all postoperative to 24 months ( P > 0.4, between-group comparisons). tion, no differences in outcomes were noted at 24 m pseudoph kic ey s that received the implant alone, co with the overall implant alone group and the phaco + group. These findings are consistent with other re 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 Probability of clinical success 0.2 8.26 3.76 3.96 9.76 8.56 6.76 0 10 20 30 40 50 60 70 80 90 100 42 htnoM 21 htnoM Implant alone ( N = 114) Phaco + implant ( N = 88) Total ( N = 202) ( n = 66/98) ( n = 57/8 ) ( n = 123/182) ( n = 54/86) ( n = 52/75) ( n = 1 6/161) Eyes achieving success (%) Percentage of eyes with avail ble data achieving success in the mITT ion at months 12 and 24. Success was d fined by eyes achieving ≥ P reduction from baseline on the sam or fewer medications without glaucoma-related secondary surgical interve tion (SSI) or intent converted to an ther procedu e. mITT, modified intent-to-trea phacoemulsificati n with intraocular lens r placement Graefes Arch Clin Exp Ophthalmol (2019) 257