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We evaluated the influence of an antioxidant and zinc nutritional supplement [the Age-Related Eye Disease Study (AREDS) formulation] on delaying or preventing progression to neovascular AMD (NV) in persons with age-related macular degeneration (AMD). AREDS subjects (n = 802) with category 3 or 4 AMD at baseline who had been treated with placebo or the AREDS formulation were evaluated for differences in the risk of progression to NV as a function of complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotype groups. We used published genetic grouping: a two-SNP haplotype risk-calling algorithm to assess CFH, and either the single SNP rs10490924 or 372_815del443ins54 to mark ARMS2 risk. Progression risk was determined using the Cox proportional hazard model. Genetics–treatment interaction on NV risk was assessed using a multiiterative bootstrap validation analysis. We identified strong interaction of genetics with AREDS formulation treatment on the development of NV. Individuals with high CFH and no ARMS2 risk alleles and taking the AREDS formulation had increased progression to NV compared with placebo. Those with low CFH risk and high ARMS2 risk had decreased progression risk. Analysis of CFH and ARMS2 genotype groups from a validation dataset reinforces this conclusion. Bootstrapping analysis confirms the presence of a genetics– treatment interaction and suggests that individual treatment response to the AREDS formulation is largely determined by genetics. The AREDS formulation modifies the risk of progression to NV based on individual genetics. Its use should be based on patient-specific genotype.

PurposeThe safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial.MethodsThis phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet. At each 4-week interval visit for 52 weeks, subjects were to be assessed to determine if rescue treatment was needed with anti-VEGF therapy.Results157 patients were enrolled. Due to gastrointestinal and hepatobiliary adverse events and the fulfilment of the primary endpoint, the trial was stopped prematurely after a second interim analysis. The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001). There was a dose-dependent trend in the number of injections over a 52-week period, with the 50 mg (n=40), 100 mg (n=39), 200 mg (n=39) and placebo (n=39) group requiring 6.7, 6.0, 4.7 and 8.1 injections, respectively.ConclusionsX-82 oral therapy in combination with pro re nata anti-VEGF injections showed non-inferiority in visual acuity outcomes while achieving a dose-dependent decrease in the number of anti-VEGF injections compared with placebo. Given the limited tolerability and safety issues observed, X-82 does not have a sufficient benefit to risk profile in treatment of patients with AMD.

To describe a new device and method for peeling membranes without forceps during vitreoretinal surgery. A novel micro-vacuum-pick (MVP) was used to peel internal limiting membrane (ILM) and/or epiretinal membrane (ERM) in 24 consecutive pars plana vitrectomy procedures. The MVP was used to create an edge in the membrane, strip the membrane from the retinal surface, and evacuate the membrane from the eye through the lumen of the device using active aspiration. The MVP was the sole device used to peel and remove ILM and/or ERM in each case. No surgical complication occurred during any case. The MVP was used to perform the fluid-air exchange in all cases in which a fluid-air exchange was performed. The MVP introduces a new method of peeling ILM and ERM without forceps. The MVP device and method eliminate the need for a separate device to create an edge in the ILM or ERM, reduce or eliminate instrument exchanges during membrane peeling, and eliminate the need for a separate extrusion cannula for fluid-air exchange. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:196-199.].

Objective: To compare peel-induced maculopathy (PIM) using surgical forceps versus the microvacuum pick (MVP). Methods: Consecutive eyes undergoing internal limiting membrane (ILM) peeling using either the MVP or forceps were assessed. En face optical coherence tomography (OCT) images at the level of the nerve fiber layer were generated for 6-month postoperative visit. The percentage of the imaged area showing PIM was termed the PIM index. PIM severity was additionally measured using a qualitative PIM severity scale. Results: Seventy-four consecutive eyes underwent ILM peeling with either the MVP (36/74; 49%) or forceps (38/74; 51%). At month-6 postoperatively, the mean PIM index for forceps was 7.7% vs 4.7% for the MVP (P < 0.001, R2 = 0.15). At 6 months, 26/38 eyes (68.5%) in the forceps group had either moderate or severe PIM compared to 12/36 eyes (33.3%) in the MVP group (P = 0.001). Conclusions: ILM peeling with the MVP resulted in lower PIM severity compared to forceps. [Ophthalmic Surg Lasers Imaging Retina 2023;54:37–42.]

OBJECTIVE: To describe the Port Delivery System with ranibizumab implant insertion procedure. METHODS: A surgical procedure based on the clinical trial program in patients with retinal diseases. RESULTS: An infusion line is placed in the infero-temporal quadrant; a superotemporal quadrant corneal traction suture is recommended. The superotemporal quadrant peritomy of 6 × 6 mm is executed with gentle, purposeful tissue handling. Generous posterior and lateral sub-Tenon's capsule dissection creates laxity for the subsequent closure. Adequate scleral hemostasis is achieved with wet-field cautery to maintain a clean field. The implant is filled under magnification with a customized formulation of ranibizumab. A precise 3.5-mm-long scleral incision (4 mm posterior and parallel to the limbus) is created to ensure proper implant fit. The exposed pars plana undergoes laser ablation to reduce vitreous hemorrhage risk. A pars plana incision is made, and the implant is inserted perpendicular to the globe and seated flush against the sclera. Complete closure of both the conjunctiva and Tenon's capsule with scleral anchoring and mild tissue overhang at the anterior limbus is performed to reduce conjunctival erosion and retraction risks. CONCLUSION: The procedure is straightforward yet requires precise preoperative and intraoperative preparation and standardized surgical techniques. [Ophthalmic Surg Lasers Imaging Retina. 2022;53:249–256.]

The real-world performance of a home telemonitoring strategy (ForeseeHome AMD Monitoring System®, Notal Vision, Inc.,Manassas VA, USA) was evaluated and compared to the device arm of the AREDS2-HOME study among patients with intermediate AMD (iAMD) who converted to neovascular AMD (nAMD). All patients with confirmed conversion to nAMD who used the home monitoring system from 10/2009 through 9/2018 were identified by Notal Vision Diagnostic Clinic’s medical records. Selected outcome variables were evaluated, including visual acuity (VA) at baseline and at conversion, and change in visual acuity (VA) from baseline to time of conversion. In total, 8991 patients performed 3,200,999 tests at a frequency of 5.6 ± 3.2 times/week. The 306 eyes that converted from iAMD to nAMD over the study period (a 2.7% annual rate) were included in the analyses. There was a median (interquartile range) change of −3.0 (0.0–(−10.0)) letters among converted eyes, 81% [95% confidence interval (72–88%)] maintained a VA ≥ 20/40 at the time of conversion, while 69% of the conversion detections were triggered by system alerts. The real-world performance of an at-home testing strategy was similar to that reported for the device arm of the AREDS2-HOME study. The home telemonitoring system can markedly increase early detection of conversion to nAMD.

According to Awh, patients enrolled in Archway had received a mean of 5 anti-VEGF injections prior to study enrollment and had good baseline vision. Prespecified ocular adverse events of special interest were more common in the Susvimo arm than in the control group during the first 40 weeks of the trial (19.0% vs 6.0%). [...]it is hoped that appropriate management of the conjunctiva, including early detection of retraction and prompt surgical repair, may reduce the risk of endophthalmitis.\" [...]Awh said most of the other ocular adverse events occurred within the first month after the implantation procedure.

To determine the prophylactic and therapeutic value of a single subthreshold 810-nanometer laser treatment in patients with high risk drusen as a manifestation of dry age-related macular degeneration in both eyes. The Prophylactic Treatment of Age-related Macular Degeneration study enrolled 1,278 eyes of 639 participants who were 50 years or older with at least 5 drusen 63 microm or more in diameter in each eye. Treatment consisted of the placement of an annular grid of 48 extrafoveal, subthreshold 810-nm diode laser applications centered at but sparing the foveola in one eye of each participant, with the fellow eye serving as a control. Development of choroidal neovascularization and change in best-corrected visual acuity were compared between treated and untreated eyes. Subthreshold laser treatment did not decrease the incidence of choroidal neovascularization in treated versus untreated eyes. A modest visual acuity benefit in treated eyes was found at 24 months (1.5 letter difference; P = .04) and in the treated eyes of participants with a baseline visual acuity between 20/32 and 20/63 (4.0 letter difference; P = .0034). However, this treatment effect was not sustained at 3 years. A single subthreshold 810-nanometer laser treatment to eyes of participants with bilateral high risk drusen is not an effective prophylactic strategy against choroidal neovascularization.