California Retina Consultants

The RHONE-X study (ClinicalTrials.gov identifier, NCT04432831) evaluated long-term safety and tolerability (primary end points), and efficacy (exploratory end points) of faricimab, a dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A) inhibitor, using a treat-and-extend (T&E) protocol in patients with diabetic macular edema (DME). Global phase 3, multicenter, nonrandomized, 2-year open-label extension study of the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) studies. Of 1622 patients who completed YOSEMITE and RHINE, 1474 patients (91%) were included in the RHONE-X trial. Patients transitioned from faricimab every 8 weeks (Q8W), faricimab T&E, or aflibercept 2.0 mg Q8W in YOSEMITE and RHINE to the RHONE-X study without requiring monthly initiation doses. All received faricimab T&E at up to 16-week intervals based on best-corrected visual acuity (BCVA) and central subfield thickness (CST), per YOSEMITE and RHINE criteria. Patients attended every month during the initial 4-month masked period, then only for T&E dosing visits (open-label arm). Analysis windows were defined for the RHONE-X study years 1, 1.5, and 2 to account for visit asynchronicity. The primary end point was incidence and severity of ocular and nonocular adverse events (AEs). Exploratory end points included change from baseline BCVA and CST, proportion of patients with absence of DME (CST < 325 μm), and treatment durability. Overall, 1204 patients (82%) completed the RHONE-X trial. The incidence of AEs leading to treatment discontinuation (1.5%) and rates of intraocular inflammation (1.3%) were low. Overall, faricimab T&E maintained visual and anatomic improvements achieved in YOSEMITE and RHINE. Adjusted mean BCVA improvements from YOSEMITE and RHINE baseline to the end of the RHONE-X trial were +10.1 letters (faricimab T&E), +11.4 letters (faricimab T&E [prior Q8W]), and +9.5 letters (faricimab T&E [prior aflibercept]); CST reductions were -198.3 μm, -202.5 μm, and -204.9 μm, respectively. At study end, more than 90% of patients achieved DME absence, regardless of prior treatment. Median number of injections over the RHONE-X trial (2 years) were 7 (faricimab T&E), 8 (faricimab T&E [prior Q8W]), and 8 (faricimab T&E [prior aflibercept]). By the RHONE-X trial completion, approximately 80% of patients received faricimab at ≥Q12W intervals. Faricimab, a dual Ang-2 and VEGF-A inhibitor, provided long-term safety, efficacy, and durability in patients with DME treated using a T&E regimen. Sustained visual and anatomic improvements were observed, with extended dosing intervals and reduced treatment burden. Faricimab was well tolerated, with a safety profile consistent with the YOSEMITE and RHINE trials. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Blended oxygen has been shown to reduce severe retinopathy of prematurity (ROP) incidence worldwide, and more recently in Uganda. Although it has been established that ROP-driven visual impairment has a substantial societal burden and that screening and treatment programs are cost-effective in low- and middle-income countries, there is limited evidence for the economic impact of prevention with appropriate oxygen management equipment (OME) in these regions. We performed a cost-utility analysis of OME implementation comparing variations ranging between most and least favorable values. Disability-adjusted life years (DALYs) were calculated with a 3% discount rate. Calculations assumed a 62.1% incidence of visual impairment in untreated severe ROP and a disability weight of 0.184 for severe visual impairment due to ROP. One set of OME costs between $677.50-$1,844.11 USD in Uganda. We found that the cost to prevent one case of ROP-driven severe visual impairment in Uganda ranges from $25.55-$543.99, with a base case (best estimate) of $168.92 per case averted. This reflects 5.18 DALYs averted over the 58-year average Ugandan lifespan and a cost of $4.97-$104.98 to avert one DALY, with a base case of $32.60 per DALY averted. In comparison, prevention of malaria via mosquito net distribution was estimated in a 2020 meta-analysis to cost $50 for every DALY averted. The high-end estimate is roughly 10% of the annual gross domestic product per capita ($1,002.30). Therefore, OME is a cost-effective means to prevent severe visual impairment among infants in Uganda. Implementation of OME in Uganda would also reflect a clear ethical and humanitarian success.

Purpose: To analyze vitreous base indentation achieved with absorbable vs permanent scleral imbrication sutures during retinal detachment repair. Methods: This retrospective, consecutive case series included patients who underwent scleral imbrication sutures with pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD) repair. Single-surgery anatomic success rate and visual acuity (VA) were assessed at 6 to 9 months postoperatively. Scleral indentation was measured by B-scan ultrasonography more than 6 weeks after surgery. Results: Sixteen patients were included. The single-surgery anatomic success rate was 88% (14 of 16) at 6 months. Vitreous base indentation greater than 2 mm, initially present in all quadrants, persisted beyond 6 weeks in 100% (13 of 13) of quadrants with polyester (Mersilene) scleral imbrication sutures and in 14% (2 of 14) with polyglactin 910 (Vicryl) scleral imbrication sutures. Median VA improved from baseline 0.36 logMAR (interquartile range [IQR], 0 to 1.15) to 0.18 logMAR (IQR, 0.01 to 0.51) postoperatively. Conclusions: Scleral imbrication sutures can produce either temporary or sustained vitreous base indentation. They may serve as a useful adjuvant to PPV for primary RRD repair when avoidance of a buckle element is desired.

Abstract Purpose: To evaluate the visual and anatomic outcomes of intravitreal faricimab monotherapy in neovascular age-related macular degeneration (nAMD) patients presenting with large submacular hemorrhage (SMH). Methods: Patients with neovascular age-related macular degeneration (nAMD) presenting with at least 50% subretinal hemorrhage (SRH) involving the fovea were identified. Patients with greater than 750 microns of total thickness of subfoveal hemorrhage were excluded. Patients were treated with faricimab as first line therapy utilizing a treat-extend-stop protocol for one year. Spectral domain optical coherence tomography (SD-OCT) and fluorescein angiogram (FA)/ indocyanine green angiography (ICG) were used to determine total CNV lesion size, SRH area size, and macular thickness. Visual acuity and SD-OCT were also obtained at each visit. Results: Six patients were identified that met the inclusion criteria. There were two males and four females. The average age of was 83.0 years. Prior to treatment, the average total CNV lesion size was 19.7mm2 and the average hemorrhage area was 14.5 mm2 for an average SRH percentage of 73.8%. The average central macular thickness (CMT) prior to treatment was 478.3 um and the average CMT 6 months after beginning treatment was 306.8 um (p=0.0031). The average CMT 1 year after treatment was 259.0um (p=0.0017). Average ETDRS letters before treatment was 48.8 letters {Snellen equivalent 20/138} with a range of 23-70 letters. Average ETDRS letters after 6 months of treatment was 60.3 letters {Snellen equivalent 20/63} with a range of 42 to 76 letters (p=0.017). Average ETDRS letters after 1 year of treatment was 64.7 letters {Snellen equivalent 20/50} with a range from 26 to 80 letters (p&lt;0.014). The average number of injections was 9.3 at 1 year. Conclusion: In patients with nAMD complicated by at least 50% SRH, there was improved vision and decreased CMT. The vision improved by over 3 lines of vision. These patients may be successfully managed with faricimab monotherapy. While visual acuity overall improved, some patients had more improvement than others likely due to the location of the CNV.

In 2024, the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee became aware of reports of coring of vial stoppers in relation to preparation of intravitreal injections. A literature review was performed to further understand and characterize this occurrence within the context of retina practice and the broader medical community. Relevant articles were identified through a systematic search of PubMed using predefined criteria. Coring can be observed when a needle punctures the rubber stopper of a medication vial, pushing a small piece or pieces of the stopper material into the container and introducing extrinsic particles into the drug product. Factors associated with coring include larger gauge needles, perpendicular needle entry, multiple-use vials, and thicker rubber stoppers. Rubber stopper thickness and composition also influence the likelihood of coring. To prevent patient safety issues from coring, filter needles are commonly used to draw up medications from vials because they are effective in mitigating particulate matter from entering syringes. No documented cases of clinical complications related to coring in ophthalmology have been identified. Coring represents an unreported phenomenon in the preparation of intraocular medications. Although there have been no safety implications in retina practice related to coring and intravitreal drug vials, these reports underscore the importance of careful medication preparation, inspection of vials, the use of appropriate needles, and adherence to best clinical practices.

Uveal melanoma (UM) is an aggressive cancer of the eye that frequently results in metastatic death. UMs are most likely to metastasize when they are small, at a time when they are difficult to distinguish from benign nevi and often observed without treatment. Unfortunately, little is known about the early genetic evolution of UM or potential biomarkers to indicate small tumors undergoing malignant transformation. Here, we performed targeted next generation sequencing for the 7 canonical UM driver mutations in 1140 primary UMs, including 131 small early-stage tumors. We found that the evolutionary burst of genetic aberrations that determines the archetypal UM subtypes and metastatic propensity has already occurred by the time most small tumors are biopsied, although a significantly larger proportion of small tumors are still evolving compared to larger tumors. We found that the 15-gene expression profile (15-GEP) support vector machine discriminant score was the best indicator of tumors in transition from low-risk Class 1 to high-risk Class 2 signature. While BAP1, SF3B1 and EIF1AX mutations were associated with poor, intermediate and good prognosis, respectively, mutation analysis was inferior to the prospectively validated 15-GEP + PRAME expression classifier for predicting metastasis-free and overall survival. These results provide a more complete picture of genetic evolution in UM, and they move us closer to a molecular definition of malignant transformation in this cancer type.

To examine the role of the ophthalmologist in screening for ocular candidiasis in patients with Candidemia . Recent evidence has shown that previously published incidence rates of endophthalmitis in Candidemia were overestimating risk due to nonuniform guidelines. Newer data suggest a very low rate of endophthalmitis in the Candidemia population. There is currently a lack of definitive data proving that retinal findings lead to significant changes in the clinical management of patients with regards to systemic treatment and overall outcomes. Given the low rates of endophthalmitis, minimal management changes with positive retinal findings, and recently published guidelines from the American Academy of Ophthalmology, we posit that ocular screening of all patients with Candidemia is not warranted. However, more research is required to better delineate high-risk features that could guide which patients would require ophthalmologic examination. Further collaboration between ophthalmology and infectious disease specialists is vital to create new evidence-based guidelines based on the recent data.

Purpose: To investigate how home optical coherence tomography (OCT) influences the clinical decision-making of retina specialists for the management of neovascular age-related macular degeneration (nAMD). Methods: In this retrospective imaging review, 15 retina specialists each evaluated 10 home OCT data segments from 29 eyes being treated for nAMD. Based on OCT data, indications were identified for when eyes should be treated, which antivascular endothelial growth factor should be used, and the specific retinal fluid and time thresholds for notification. Results: Withholding treatment was recommended in 64 (42.7%) of 150 data segments (95% CI, 34.7-50.6), whereas 100% of eyes received treatment on the last day of each data segment. Treatment was recommended in 86 cases (57.3%), with treatment occurring 7 or more days before the actual treatment was advised in 52 (60.5%) of 86 data segments. This earlier treatment would have prevented the accumulation of intraretinal fluid (IRF), subretinal fluid (SRF), and total retinal fluid for 69.1 nL, 162.2 nL, and 231.2 nL days. Retina specialists chose a different type of treatment agent in 35 (40%) of 86 cases. The following notification values were set: IRF, mean 9.8 ± 14.9 nL (median, 5; IQR, 5); SRF, mean 10.2 ± 16.1 nL (median, 5.5; IQR, 5); total retinal fluid, mean 15.2 ± 24.0 nL (median, 10; IQR, 5). The time-based notification interval was set at a mean of 34.7 ± 21.9 days (median, 30; IQR, 2). Conclusions: Home OCT-based decision-making by retina specialists differed substantially from actual clinical care. Home OCT has the potential to facilitate personalized care in nAMD.