C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial.

PURPOSE: The complement pathway may play a key role in the pathogenesis of age-related macular degeneration (AMD). The safety and efficacy of avacincaptad pegol (Zimura, IVERIC bio Inc, New York, NY), a C5 inhibitor, were assessed in participants with geographic atrophy (GA) secondary to AMD (GATHER1 Study). DESIGN: International, prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial. PARTICIPANTS: A total of 286 participants with GA secondary to AMD. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the mean rate of change in GA over 12 months measured by fundus autofluorescence (FAF) at 3 timepoints: baseline, month 6, and month 12. RESULTS: The reduction in the mean rate of GA growth (square root transformation) over 12 months was 27.4% (P = 0.0072) for the avacincaptad pegol 2 mg cohort and 27.8% (P = 0.0051) for the avacincaptad pegol 4 mg cohort compared with their corresponding sham cohorts. The results for both dose groups were statistically significant. Avacincaptad pegol was generally well tolerated after monthly administration over 12 months. There were no avacincaptad pegol-related adverse events (AEs) or inflammation. Further, there were no ocular serious AEs (SAEs) and no cases of endophthalmitis. The most frequent ocular AEs were related to the injection procedure. CONCLUSIONS: Intravitreal administration of avacincaptad pegol 2 mg and 4 mg led to a significant reduction of GA growth in eyes with AMD over a 12-month period. Because C5 inhibition theoretically preserves C3 activity, it may offer additional safety advantages. A second confirmatory pivotal clinical trial is underway to confirm the efficacy and safety of avacincaptad pegol in slowing the GA growth (GATHER2 Study).

SUPPLEMENTAL SCLERAL BUCKLE IN THE ERA OF SMALL INCISION VITRECTOMY AND WIDE-ANGLE VIEWING SYSTEMS.

PURPOSE: To evaluate trends and outcomes of scleral buckle as adjunct to pars plana vitrectomy for management of retinal detachment. METHODS: Retrospective case series including 300 consecutive cases of retinal detachment that underwent pars plana vitrectomy. The series was divided into three consecutive groups: Group A (first 100 cases), Group B (second 100 cases), and Group C (third 100 cases). RESULTS: Three hundred eyes of 289 patients, mean age 61.0 years, were included in the study. The mean follow-up was 31.3 months for Group A, 28.5 months for Group B, and 12.0 months for Group C (P < 0.001). The baseline mean logarithm of the minimum angle of resolution equivalent was 1.58 for Group A, 1.31 for Group B, and 1.33 for Group C (P = 0.15). Supplemental scleral buckle was performed in 53% of Group A, 35% of Group B, and 17% of Group C (P < 0.001). Single surgery reattachment rate was 93% for Group A, 95% for Group B, and 97% for Group C (P = 0.48). The mean change in logarithm of the minimum angle of resolution equivalent was -0.84 for Group A, -0.81 for Group B, and -0.71 for Group C (P = 0.50). CONCLUSION: The study demonstrates decreasing use of supplemental scleral buckle in the era of small gauge vitrectomy surgery and wide-angle viewing systems while the outcomes remain stable. Selective, less frequent use of supplemental scleral buckle is compatible with good anatomical and visual outcomes.

Rate of sclerotomy suturing in 23-gauge primary vitrectomy.

PURPOSE: To evaluate the rate of sclerotomy suturing in a large series of primary 23-gauge vitrectomies. METHODS: Retrospective chart review of 23-gauge transconjunctival pars plana vitrectomies performed between 2008 and 2012 in a multisurgeon retina practice. Patients with a history of retinal surgery, combination of vitrectomy and scleral buckling surgery, or intraoperative conversion of a sclerotomy to 20-gauge were excluded from the study. Vitrectomies were divided into two types according to their degree of complexity and intraoperative use of instrumentation. Demographic and clinical data were gathered from the chart. Location and number of sutured sclerotomies were obtained from the operative report. RESULTS: A total of 589 eyes from 569 patients were included in this study. At least 1 sclerotomy was sutured in 227 eyes (38.5%): 69 (30.4%) had 1 sutured sclerotomy, 52 (22.9%) had 2 sutured sclerotomies, and 106 (46.7%) had 3 sutured sclerotomies. Sclerotomy suturing was significantly related to the surgical technique (P < 0.001), type of tamponade agent (P = 0.048), and complexity of the vitrectomy (P < 0.001). The incidence of postoperative hypotony at Day 1 was 2.2% and all cases returned to normal intraocular pressure at 1 week. There were no recognized complications related to sclerotomies regardless of suturing. CONCLUSION: The factors that increased the rate of sclerotomy suturing were the absence of tamponade agent and higher complexity of the procedure. There was a high variability in the rate of suturing between the surgeons.

International Validation of Myopic Traction Maculopathy Staging System.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the interobserver agreement of the myopic traction maculopathy (MTM) staging system (MSS). PATIENTS AND METHODS: Each observer was asked to look at the MSS Table and then identify, in each optical coherence tomography scan, one among four stages of MTM in the retina, one among three stages in the fovea, and, as secondary findings, the presence or absence of an outer lamellar macular hole and the presence or absence of epiretinal abnormalities. The interobserver agreement value was calculated using the Gwet's AC1 unweighted and AC2 weighted statistics. The outcomes were interpreted as poor (<0.00), slight (0.00 to 0.20), fair (0.21 to 0.40), moderate (0.41 to 0.60), substantial (0.61 to 0.80), or almost perfect (0.81 to 1.00) agreement. RESULTS: The agreement, among 65 participants, was 0.62 (AC1) and 0.77 (AC2) for the retina stage; 0.63 (AC1) and 0.81 (AC2) for the fovea stage; 0.56 (AC1) for the outer lamellar macular hole; and 0.26 (AC1) for epiretinal abnormalities. CONCLUSION: The MSS is highly reproducible and helps ophthalmologists to share information on MTM in a more accurate and reliable way. [Ophthalmic Surg Lasers Imaging Retina 2023;54(3):153-157.].

Superior Wide-Base Internal Limiting Membrane Flap Transposition for Macular Holes: Flap Status and Outcomes.

PURPOSE: Internal limiting membrane (ILM) flap techniques are used for the management of macular holes (MHs). Status of the flap after surgery often is uncertain. The current study evaluated the status of the ILM flap after MH surgery with superior wide-base ILM flap transposition (SWIFT). DESIGN: Retrospective consecutive case series. PARTICIPANTS: Eyes undergoing SWIFT for MH. METHODS: Data were collected on demographic characteristics, preoperative and postoperative visual acuity (VA), and MH status. OCT and indocyanine green (ICG) fluorescence were used to evaluate the MH and the ILM flap status. MAIN OUTCOME MEASURES: Status of MH, ILM flap position, and ILM flap integrity. RESULTS: Seventeen eyes of 17 patients with a mean age of 65.3 years and mean follow-up of 11.6 months were included in the study. Thirteen eyes had 1 or more high-risk characteristics. Four eyes (24%) were highly myopic, 6 eyes (35%) had chronic MH, and 3 eyes (18%) had a history of prior MH surgery and ILM removal. The mean MH basal diameter was 899.4 µm and the mean inner diameter was 516.1 µm. In 6 eyes, the MH inner diameter was 650 µm. The baseline mean VA equivalent was 0.88 logarithm of the minimum angle of resolution (logMAR). The MH closed in 16 eyes (94%). Indocyanine green fluorescence imaging demonstrated complete coverage of the MH by the ILM flap in 14 eyes (82%), partial coverage in 1 eye (6%), and no coverage in 2 eyes (12%). In the 2 eyes without ILM flap coverage, the MH was closed in 1 eye and remained open in 1 eye. Non-center-involving folding of the ILM flap was present in 4 eyes (24%). At the last follow-up visit, the mean VA equivalent was 0.54 logMAR. CONCLUSIONS: Superior wide-base ILM flap transposition is a useful technique for the management of high-risk MHs, including persistent MHs with previously removed ILM. After surgery, the ILM flap may be visualized by ICG fluorescence imaging. After SWIFT, ICG imaging indicates that the ILM flap is intact and in a good position in most cases.

Retinal detachment after primary pneumatic retinopexy.

PURPOSE: To describe the characteristics and outcome of patients who required retinal reattachment surgery after pneumatic retinopexy for rhegmatogenous retinal detachment. METHODS: Retrospective review of patients who underwent retinal reattachment surgery after pneumatic retinopexy at a multioffice retina practice. Patients with <6 months follow-up were excluded. RESULTS: Two hundred eighty-nine eyes from 289 patients underwent pneumatic retinopexy and 50 eyes of 50 patients were included in this study. The mean follow-up time was 28 +/- 20.4 months (range, 6-76 months). The most common cause of detachment was development of a new retinal detachment (72%) associated with the development of a new retinal break (75%). Increased or persistent subretinal fluid associated with the original detachment was the cause of detachment in 28% of eyes. The mean number of procedures for retinal reattachment was 1.4 +/- 0.9 (range, 1-5) with the majority (72%) reattached with 1 surgery. The mean visual acuity on presentation was 20/125 (range, 20/20-hand movements) and at the final visit was 20/50 (range, 20/20-counting fingers). CONCLUSION: Retinal reattachment surgery after pneumatic retinopexy is successful with anatomic and functional improvement. The most common cause of detachment is the formation of new inferior retinal detachment caused by a new break.