Intravitreal Ranibizumab Injections Research Articles

Different Retinopathy of Prematurity Severity, Onset Therapy and Outcomes in Triplet Babies: A Case Report

Introduction : Retinopathy of prematurity (ROP) is a vasoproliferative disease of the premature infants, characterized by abnormal vascularization at the junction of vascular and avascular retina. Intravitreal anti-VEGF injection is one of promising management of ROP. The aim is to present the therapy outcomes of triplet babies with different severity and onset therapy.
 Case Illustration : This case shows ROP in triplets born at 25-26 weeks gestational age. First baby, weighed 630 g with Bilateral Stage 2 Zone II Posterior with Plus Disease treated with intravitreal ranibizumab injection at 11 weeks (PMA 36-37 weeks). Second baby, weighed 620 g and get bilateral intravitreal ranibizumab injection a week after first baby, left eye got worse on first week, but getting better on the last follow up. Third Baby, weighed 750 g with bilateral Stage 3 Zone I with Plus Disease (worst eye condition), but because he had worst general condition, so the latest got screening, got no intervention. Two babies were treated with anti-VEGF therapy – bevacizumab. All babies has outcome regression, no recurrence of ROP in those short term end point, and no adverse reactions were observed until the last follow up at 27 weeks old (PMA 52-53 weeks) recorded for all babies.
 Discussion : 
 Conclusion : Primary prevention through well-managed screening programme for premature infants was the more effective way to manage the ROP. Intravitreal anti-VEGF treatment could be promising for management of ROP if it was given on the right time and early stadium.

Trends in Anti-Vascular Endothelial Growth Factor Original Medicare Part B Claims in the United States, 2014–2019

ABSTRACT Purpose To characterize trends in use of and expenditure for the intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents aflibercept, ranibizumab, and bevacizumab among the population enrolled in Original Medicare from 2014 to 2019. Methods The Centers for Medicare and Medicaid Services Physician and Other Supplier Public Use File was used to extract Medicare Part B fee-for-service outpatient injection claims data submitted by ophthalmologists. Multivariable linear regression models were used to evaluate the association between reimbursement, ophthalmologist availability, and agent administration rate. Results Between 2014 and 2019, 17,588,995 intravitreal injection claims were filed by 4218 US ophthalmologists. Medicare costs for anti-VEGF injections increased from 2.51 B USD in 2014 to 4.02 B USD in 2019. Increased state-level ophthalmologist availability and incremental increases in average reimbursement amounts were found to be significantly associated with a 6.8-fold variation in 2019 overall anti-VEGF injection rates across states. Conclusions Medicare injection rates and costs for anti-VEGF injections have both increased between 2014 and 2019, largely driven by increased aflibercept use. There is a significant association between ophthalmologist availability and anti-VEGF injection rate on the state level, suggesting access to care may contribute to the observed state-level disparities in intravitreal injection rates. Further characterization of factors contributing to the state-level variation in injection rates of individual anti-VEGF agents may help inform interventions promoting equitable access to and use of these drugs.

The Effect of Systemic Parameters and Baseline Characteristics in Short-Term Response Analysis with Intravitreal Ranibizumab in Treatment-Naive Patients with Neovascular Age-Related Macular Degeneration.

Anti-vascular endothelial growth factor drugs keep being the main therapy for neovascular age-related macular degeneration (AMD). Possible predictive parameters (demographic, biochemical and/or inflammatory) could anticipate short-term treatment response with ranibizumab. 46 treatment-naive patients were included in a prospective observational study. They underwent three monthly injections of intravitreal ranibizumab for neovascular AMD and the clinical examination was made at baseline and one month after the third injection. Demographic characteristics, co-morbidities and concomitant treatments were recorded at the baseline visit. Biochemical parameters, complete blood count and inflammation biomarkers were also measured at these times. Uric Acid was found to be statistically significant with a one-point difference between good and poor responders in both basal and treated patients, but only in basal parameters was statistical significance reached (p = 0.007 vs. p = 0.071 in treated patients). Cholesterol and inflammatory parameters such as white blood cell count and neutrophils were significantly reduced over time when treated with intravitreal ranibizumab. On the other hand, women seemed to have a worse prognosis for short-term response to intravitreal ranibizumab treatment. Uric acid may help identify possible non-responders before initial treatment with ranibizumab, and cholesterol and white blood cells could be good candidates to monitor short-term response to ranibizumab treatment.

Risk of Endophthalmitis Based on Cumulative Number of Anti-VEGF Intravitreal Injections

PurposeTo determine the rate of endophthalmitis in eyes undergoing intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) based on cumulative number of injections per eye. DesignRetrospective cohort study ParticipantsPatients from a single center undergoing IVI of ranibizumab, aflibercept, and/or bevacizumab MethodsEyes were divided into quartiles based on injection number causative of endophthalmitis between January 1, 2011 and June 1, 2022. Main outcome measuresInterquartile clinical outcomes and cumulative risk of endophthalmitis per injection and per eye ResultsA total of 43,393 eyes received 652,421 anti-VEGF injections resulting in 231 endophthalmitis cases (0.035% per-injection, 1 in 2857), of which 215 were included. The cumulative endophthalmitis risk increased from 0.0018% (1 in 55,556) after 1 injection to 0.013% (1 in 7692) after 11 injections (0.0012 percentage point change in risk per injection), vs. 0.014% (1 in 7143) after 12 injections to 0.025% (1 in 4000) after 35 injections (0.00049 percentage point change in risk per injection), vs. 0.025% (1 in 4000) after 36 injections to 0.031% (1 in 3226) after 66 injections (0.00017 percentage point change in risk per injection), vs. 0.031% (1 in 3226) after 63 injections to 0.033% (1 in 3030) after 126 injections (0.000042 percentage point change in risk per injection) (p <0.001). Similarly, the cumulative endophthalmitis risk per eye increased from 0.028% (1 in 3,571) to 0.20% (1 in 500) between injections 1-11 (0.018 percentage point change in risk per injection), vs. 0.21% (1 in 476) to 0.38% (1 in 263) between injections 12-35 (0.0075 percentage point change in risk per injection), vs. 0.38% (1 in 263) to 0.46% (1 in 217) between injections 36-66 (0.0026 percentage point change in risk per injection), vs. 0.46% (1 in 217) to 0.50% (1 in 200) between injections 67-126 (0.00063 percentage point change in risk per injection) (p <0.001). ConclusionsThe cumulative endophthalmitis risk per injection and per eye increased with greater number of injections received but appeared to do so at a higher rate during earlier injections and at a lower rate further into the treatment course.

A study of the relationship between cytokine levels and the response to anti-VEGF therapy in polypoid choroidal vasculopathy with different choroidal thicknesses.

Polypoidal choroidal vasculopathy (PCV) is an irreversible retinal choroidal disease. Individuals with PCV exhibit diverse baseline characteristics, including systemic characteristics, ocular traits, metabolic factor levels, and different responses to intravitreal anti-VEGF therapy. This study aims to investigate the pathogenesis of PCV by analyzing the systemic characteristics, ocular traits, and cytokine levels at baseline within a cohort of patients who exhibit different responses to anti-VEGF treatment. We conducted a retrospective analysis involving 80 eyes diagnosed with PCV. Patients were categorized into two groups based on responses to suboptimal intravitreal ranibizumab injection therapy: those with suboptimal responses and optimal responses. Aqueous humor samples were collected from the experimental eyes, and cytokine expression levels were assessed using cytometric bead array analysis. All subjects were further stratified into two groups according to the median choroidal thickness. Subsequently, logistic regression analysis and the ROC curve were employed to examine the relationship between cytokine expression levels, choroidal thickness, and anti-VEGF response. The results revealed that compared to the group of optimal anti-VEGF response, the choroid in the suboptimal response group exhibited a significantly greater thickness. Additionally, compared to the suboptimal anti-VEGF response group, the expression levels of VEGF and VCAM-1 were markedly lower observed in the optimal anti-VEGF response group, while TNF-α showed the opposite trend. Logistic regression analysis indicated that VEGF, VCAM-1, and TNF-α in the aqueous humor were independent risk factors for a suboptimal anti-VEGF response. After adjusting other risk factors, the risk of suboptimal anti-VEGF response decreased to 0.998-fold, 0.997-fold, and 1.294-fold. The AUC values for VEGF, VCAM-1, and TNF-α were determined to be 0.805, 0.846, and 0.897, respectively. Furthermore, the risk of VEGF, VCAM-1, and TNF-α were significantly associated with an increased risk of suboptimal anti-VEGF response after correction for risk factors in the thick choroid group. Our study demonstrated that PCV exhibits systemic and ocular characteristics variations based on different anti-VEGF responses. The levels of cytokines in aqueous humor were found to have a significant correlation with the anti-VEGF response in PCV. VEGF, VCAM-1, and TNF-α are potential targets for assessing treatment response in thick choroidal PCV.

Aflibercept or ranibizumab for diabetic macular edema.

Vascular endothelial growth factor (VEGF) is the primary substance involved in retinal barrier breach. VEGF overexpression may cause diabetic macular edema (DME). Laser photocoagulation of the macula is the standard treatment for DME; however, recently, intravitreal anti-VEGF injections have surpassed laser treatment. Our aim was to evaluate the efficacy of intravitreal injections of aflibercept or ranibizumab for managing treatment-naive DME. This single-center, retrospective, interventional, comparative study included eyes with visual impairment due to treatment-naive DME that underwent intravitreal injection of either aflibercept 2 mg/0.05 mL or ranibizumab 0.5 mg/0.05 mL at Al-Azhar University Hospitals, Egypt between March 2023 and January 2024. Demographic data and full ophthalmological examination results at baseline and 1, 3, and 6 months post-injection were collected, including the best-corrected distance visual acuity (BCDVA) in logarithm of the minimum angle of resolution (logMAR) notation, slit-lamp biomicroscopy, dilated fundoscopy, and central subfield thickness (CST) measured using spectral-domain optical coherence tomography. Overall, the 96 eyes of 96 patients with a median (interquartile range [IQR]) age of 57 (10) (range: 20-74) years and a male-to-female ratio of 1:2.7 were allocated to one of two groups with comparable age, sex, diabetes mellitus duration, and presence of other comorbidities (all P >0.05). There was no statistically significant difference in baseline diabetic retinopathy status or DME type between groups (both P >0.05). In both groups, the median (IQR) BCDVA significantly improved from 0.7 (0.8) logMAR at baseline to 0.4 (0.1) logMAR at 6 months post-injection (both P = 0.001), with no statistically significant difference between groups at all follow-up visits (all P >0.05). The median (IQR) CST significantly decreased in the aflibercept group from 347 (166) µm at baseline to 180 (233) µm at 6 months post-injection, and it decreased in the ranibizumab group from 360 (180) µm at baseline to 190 (224) µm at 6 months post-injection (both P = 0.001), with no statistically significant differences between groups at all follow-up visits (all P >0.05). No serious adverse effects were documented in either group. Ranibizumab and aflibercept were equally effective in achieving the desired anatomical and functional results in patients with treatment-naïve DME in short-term follow-up without significant differences in injection counts between both drugs. Larger prospective, randomized, double-blinded trials with longer follow-up periods are needed to confirm our preliminary results.

Pharmacoeconomic analysis of anti-angiogenic drugs for diabetic macular edema

This study comparatively evaluates the clinical and economic feasibility of faricimab and other angiogenesis inhibitors in patients with DME. This article analyzed literature on the efficacy and safety of intravitreal injections (IVI) of ranibizumab 0.5 mg, aflibercept 2 mg, and faricimab 6 mg. A model of medical care was developed for patients with DME receiving anti-angiogenic therapy. Pharmacoeconomic analysis was performed using cost minimization and budget impact analysis (BIA) methods. Modeling time horizon was 2 years. The research was performed from the perspective of the healthcare system of the Russian Federation. The efficacy and safety of faricimab in a personalized regimen (up to one IVI in 16 weeks) are comparable to those of aflibercept and ranibizumab, administered in various regimens. The use of faricimab is associated with the lowest number of IVIs. Over 2 years, the maximum costs of drug therapy were associated with the use of ranibizumab (about 914 thousand rubles), while the minimum costs were associated with the use of faricimab (614 thousand rubles). The reduction in inpatient care costs with faricimab therapy was 36% compared to aflibercept (216 and 201 thousand rubles in inpatient and day hospitals, respectively) and 82% compared to ranibizumab (486 and 451 thousand rubles in inpatient and day hospitals, respectively). BIA demonstrated that the use of faricimab will reduce the economic burden on the healthcare system by 11.3 billion rubles (9.8%) over 2 years. The use of faricimab is a cost-effective approach to treatment of adult patients with DME in Russia.

Characteristics of Patients Who Drop Out of Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema Associated with Branch Retinal Vein Occlusion.

To investigate the dropout rate of anti-vascular endothelial growth factor (VEGF) treatment for macular edema (ME) secondary to branch retinal vein occlusion (BRVO) and identify the characteristics of dropout cases. We studied 235 eyes of 235 treatment-naïve BRVO-ME patients receiving intravitreal injection of ranibizumab. Additional intravitreal anti-VEGF drug was given when ME relapsed or persisted, and photocoagulation was performed as needed. Adherence until treatment completion was defined as disappearance of ME within 2 years after the first injection without recurrence for more than 6 months or mild ME remaining but no visual deterioration for more than 6 months without additional anti-VEGF drug. In patients with ME recurrence, those who were followed for more than 2 years were considered adherence, and those followed for less than 2 years were considered dropout. The clinical course and background of the two groups were compared. 179 patients (76.2%) adhered to treatment and 56 patients (23.8%) dropped out. Mean follow-up periods in adherence and dropout groups were 23.4 and 7.1 months, respectively. There were no significant differences between the two groups in demographic and baseline factors of age, gender ratio, distance from home to hospital, visual acuity, and foveal thickness (FT). At the last follow-up, visual acuity was significantly poorer in the dropout group than in the adherence group (0.23 vs. 0.11 logMAR, p=0.003), and FT was significantly greater in the dropout group than in the adherence group (316 vs. 273 µm, p=0.002). Reasons for dropout included patient declining further treatment in 12.5%, progression of dementia in 8.9%, others, and unknown in 64.3%. The clinical outcome of patients who dropped out of anti-VEGF therapy for BRVO-ME was worse compared to patients who adhered to therapy, and the reasons for discontinuation varied.

Potential Risk Factors for Ocular Pain in Patients Undergoing Multiple Intravitreal Injections of Anti-Vascular Endothelial Growth Factor.

To assess ocular pain in patients undergoing multiple intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) who have previous factors that may influence pain sensitivity. This is a prospective, observational, case series study involving patients who underwent multiple (≥3) pro re nata intravitreal injections of ranibizumab or aflibercept to treat any cause of chorioretinal vascular disease. Ocular pain was assessed by the numerical analog scale during intravitreal injection. For this study, the main variable was ocular pain and the secondary variables included age, sex, previous history of glaucoma, primary retinal vascular disease, severe dry eye history, trigeminal pain, scleral buckle surgery, collagen diseases, fibromyalgia, severe migraine history, pars plana vitrectomy, scleral thickness measurements, and type of anti-VEGF. In a total of 894 patients, 948 eyes (4822 intravitreal injections), 793 patients (88.6%) had ocular pain sensitivity between no pain to mild pain, 80 patients (8.9%) had moderate ocular pain, 15 patients (1.6%) had severe ocular pain, and 6 patients (0.7%) had extremely severe ocular pain. Patients with severe dry eye (p = 0.01) and previous history of scleral buckle surgery (p = 0.01) showed a significant correlation with ocular pain during intravitreal injection. Pars plana scleral thickness (>550 um) and diabetic neuropathy were associated with ocular pain but did not meet the criteria for statistical significance (p = 0.09 and p = 0.06, respectively). Dry eye and prior scleral buckle surgery may contribute to pain associated with intravitreal injection. These issues should be taken into consideration in patients undergoing multiple intravitreal injections.

THE EFFECT OF DIFFERENT FORMS OF INTRAVITREAL RANIBIZUMAB ADMINISTRATION ON PAIN

Objectives: To examine the effect of using the prefilled syringe formulation of intravitreal ranibizumab (IVR) on pain. Materials-Methods: 30 patients received bilateral IVR injection due to diabetic retinopathy and macular edema and 30 eyes of these patients that received ready-to-use (PFS) IVR were considered as group 1, and the 30 eyes that received conventional IVR by withdrawing from the vial were considered as group 2. Patients who had previously received intravitreal injection, had intraocular surgery, used any eye drops, and were unable to cooperate with the assesment were excluded from the study. Pain experienced during the injection was assessed by using the numerical rating scale (NRS) and the verbal rating scale (VRS). Results: The mean age of 30 female patients evaluated was 60.3 ±7.94 years. While the NRS was 3.70±0.79 in Group 1, it was 4.23±0.77 in Group 2, the difference was statistically significant. (p = 0.02). While the VRS was 2.13±0.34 in Group 1, it was found to be 3.0± 0.58 in Group 2, the difference was statistically significant. (p). =0.02) Conclusions: IVR application in ready-to-use formulation causes less pain during intravitreal injection.

Intravitreal ranibizumab injection is associated with an increased risk of chronic kidney disease: a population-based study in Taiwan

Systemic vascular endothelial growth factor (VEGF) blockade has been the top adjunctive chemotherapy since 1990. Anti-VEGF therapy has also been associated with worsened renal function in some patients. However, the association between patient outcomes and use of intravitreal VEGF inhibitors remains controversial. Thus, it is necessary to determine the action mechanism and long-term renal effects of ranibizumab. The National Health Insurance Research Database (NHIRD) is one of the largest global databases that are extensively used for epidemiological research. NHIRD contains the medical information of all insureds, such as inpatient, outpatient, emergency, and traditional Chinese medicine records. We selected subjects aged ≥ 20 years who recently administered ranibizumab for the ranibizumab cohort. Non-ranibizumab cohort consisted of subjects who did not receive ranibizumab, and the index date was a random date between 2008 and 2018. We excluded subjects with missing sex and age records and those in which the date of primary outcome was before the index date. The two cohorts were matched via 1:1 propensity score matching based on sex, age, index year, hypertension, diabetes mellitus, hyperlipidemia, stroke, coronary artery disease, alcoholism, chronic obstructive pulmonary disease, and age-related macular degeneration, retinal vein occlusion, and diabetic macular edema. Medical confounders were angiotensin I-converting enzyme inhibitors, statins, corticosteroids, VEGF inhibitors including bevacizumab and aflibercept, lithium, amphotericin B, adefovir, NSAIDS, cisplatin, and calcineurin inhibitors. Among 48,248 participants aged ≥ 20 years, 24,136 (50%) received ranibizumab (13,565 male [56.20%] and 10,571 female [43.80%]). Moreover, 24,136 participants who did not receive ranibizumab were matched by age, sex, comorbidities, and medications. Subjects who received ranibizumab exhibited a significantly higher risk of CKD than those who did not receive ranibizumab (adjusted hazard ratio = 1.88, 95% CI = 1.79–1.96). Our findings revealed that exposure to intravitreal ranibizumab is an independent risk factor for CKD. Therefore, physicians and ophthalmologists should make the patients aware of such a correlation to increase patient safety and decrease the CKD burden.

Outcomes of Intravitreal Injection of Ranibizumab as Primary Monotherapy for treatment-requiring Retinopathy of Prematurity

Outcomes of Intravitreal Injection of Ranibizumab as Primary Monotherapy for treatment-requiring Retinopathy of Prematurity

Clinical Efficacy of Preoperative and Intraoperative Intravitreal Ranibizumab as Adjuvant Therapy of Ahmed Glaucoma Valve Implantation Combined with Vitrectomy in the Management of Neovascular Glaucoma with Diabetic Vitreous Hemorrhage.

Neovascular glaucoma (NVG) secondary to proliferative diabetic retinopathy (PDR) is a devastating ocular disease with poor prognosis. Intravitreal ranibizumab injection (IVR) has been used as adjuvant therapy of surgical interventions preoperatively or intraoperatively. This study aimed to determine the efficacy and safety of combined IVR as adjuvant therapy in treating NVG with vitreous hemorrhage (VH) in PDR. A total of 39 NVG patients with VH (39 eyes) received IVR 3 to 5 days before surgery, and then they were assigned to either pars plana vitrectomy (PPV) + Ahmed glaucoma valve (AGV) implantation (Group 1, n = 22) or PPV + AGV implantation + intraoperative IVR (Group 2, n = 17). Patients were followed up for at least 9 months. Intraocular pressure (IOP), anti-glaucoma medications, best corrected visual acuity (BCVA), surgical success rates and postoperative complications were compared. Results showed that IOP decreased promptly after surgery and was notably maintained at a mid-term follow-up in both groups, and no significant differences were observed (all p > 0.05). Additional intraoperative IVR significantly reduced postoperative recurrent VH and iris neovascularization (p = 0.047, p = 0.025, respectively). There was no remarkable difference in postoperative anti-glaucoma medications, BCVA and complications between two groups (all p > 0.05). In conclusion, preoperative and intraoperative IVR as adjuvant therapy of AGV implantation combined with PPV could be a safe and effective treatment for NVG with VH in PDR. An additional intraoperative anti-VEGF injection could significantly reduce postoperative VH and iris neovascularization.

Role of Novel Inflammatory Factors in Central Retinal Vein Occlusion with Macular Edema.

Background and Objectives: To investigate associations among the aqueous humor levels of novel inflammatory factors, including FMS-related tyrosine kinase 3 ligand (Flt-3L), fractalkine, CXC chemokine ligand 16 (CXCL-16), and endocan-1; the severity of macular edema in central retinal vein occlusion (CRVO); and the prognosis of CRVO with macular edema after antivascular endothelial growth factor (VEGF) therapy. Materials and Methods: Aqueous humor was obtained during anti-VEGF treatment with intravitreal ranibizumab injection (IRI) in patients with CRVO and macular edema (n = 19) and during cataract surgery in patients with cataracts (controls, n = 20), and the levels of VEGF and novel inflammatory factors were measured. Macular edema was evaluated by central macular thickness (CMT) and neurosensory retinal thickness (TNeuro), and improvement was evaluated by calculating the percentage change in CMT and TNeuro from before to 1 month after IRI. Results: The levels of VEGF and the novel inflammatory factors were significantly higher in the CRVO group, and the levels of Flt-3L, CXCL-16, and endocan-1 were significantly correlated with each other and with the aqueous flare value. Baseline levels of Flt-3L, CXCL-16, and endocan-1 had a significantly negative correlation with the change in CMT, and the baseline level of CXCL-16 was significantly negatively correlated with the change in TNeuro. Conclusions: Relations among novel inflammatory factors should be further investigated. These findings may help improve understanding of macular edema in CRVO patients and aid the development of new treatments targeting novel inflammatory factors.

Biochemical and microstructural determinants of the development of serous retinal detachment secondary to retinal vein occlusion

PurposeTo study the alteration of cytokine factors in aqueous humor and retinal microstructure in the formation of serous retinal detachment (SRD) secondary to retinal vein occlusion. MethodsThe subjects were 39 patients with RVO, of whom 31 patients had SRD (RVO-SRD). Spectral Domain Optical Coherence Tomography (SD-OCT) was used to measure the completeness of photoreceptor inner segment/outer segment (IS/OS) and the external limiting membrane (ELM) as well as the structure of RVO-SRD, including the height and shape of SRD. The aqueous humor was collected before intravitreal injection of Ranibizumab. The concentrations of VEGF, MCP-1, IL-8, IL-6, b-FGF and TNF-α in the aqueous humor were measured. All patients participated in the 6-month follow-up examinations, which included visual acuity, intraocular pressure, ophthalmologic examination, and SD-OCT. The time of recurrence of RVO-SRD was recorded. ResultsThe formation of SRD was associated with the area of congested vein, disrupted IS/OS, ELM layers and high VEGF, MCP-1, IL-8, IL-6 levels. However, the height and shape of SRD were not relevant to any inflammatory factors. Moreover, high levels of MCP-1, IL-8 and IL-6 were found in large areas of congested veins. High levels of MCP-1 and IL-6 were observed in the patients with incomplete IS/OS and ELM. The recurrence of SRD was related to the high MCP-1 level. ConclusionHigh concentrations of cytokine factors in aqueous humor could induce vascular leakage, exacerbate the extent of macular edema, disrupt the structure of ELM and IS/OS, and develop SRD in RVO.

CHOROIDAL NEOVASCULARIZATION IN A CHILD WITH DOWN SYNDROME

Purpose: To report a case of Down syndrome with myopic choroidal neovascularization (CNV) and the treatment outcome. Methods: Case report. Main outcome measures include refractive error, fundus examination, optical coherence tomography (OCT), OCT angiography (OCTA), fluorescein angiography (FA), anti-vascular endothelial growth factor (VEGF) injections. Results: A 12-year-old boy with Down syndrome presented at a regular check-up with decreased visual acuity (VA) with macular degeneration in the left eye. The best-corrected VA was 0.6 in the right eye and 0.1 in the left eye, which decreased from 0.3 1 year ago. The refractive error (spherical equivalent) was -5.25 diopters (D) in the right eye and -8.00 D in the left eye. Detailed examinations were performed under general anesthesia. The fundus examination showed macular degeneration with retinal pigment epithelium (RPE) atrophy, pigmentary changes, and fibrous tissue in the left eye. OCT showed CNV at the macula with edema, and OCTA showed spreading CNV above the RPE at the macula in the left eye. FA showed hyperfluorescence in the early phase and late dye leakage from the CNV. Intravitreal ranibizumab injections were administered twice within 2 months, and he maintained a VA of 0.1 in the left eye. Conclusion: CNV and associated macular degeneration may occur in Down syndrome with high myopia possibly because of the abnormal choroidal structure. In children with Down syndrome, regular fundus examinations with OCT are important for early detection and treatment of CNV.

The role of optical coherence tomography angiography in dome-shaped maculopathy

Purpose: To demonstrate the role of optical coherence tomography angiography (OCT-A) in the management of dome-shaped maculopathy (DSM). Methods: Retrospective case review. Results: A 52-year-old woman was referred to our retina service for potential bilateral choroidal neovascular membrane (CNVM) and blurry vision bilaterally. Initial spectacle-corrected visual acuity (VA) was 20/30-2 in the right eye (RE) and 20/30+2 in the left eye (LE). DSM was diagnosed on OCT. In both eyes, OCT B-scan passing through the fovea showed shallow, irregular RPE elevation (SIRE) suspicious of occult (type 1) CNVM. The outer retina and choriocapillaris angiograms showed a zone of nonexudative CNVM in the RE and exudative CNVM in the LE. Given the persistent SRF with CNVM in the LE, we elected to perform intravitreal injections of ranibizumab 0.5 mg on a treat and extend regimen. Upon the most recent follow-up, the best corrected VA improved to 20/20 in the LE with no persisting SRF. Conclusion: We present a case where assessing disease progression, the development of CNVM and evaluating the efficiency of therapies were realized through the application of novel OCT-A technology. This diagnostic tool may be used to guide clinicians in their management of DSM, as demonstrated through our experience. OCT-A can also make it possible to visualize nonexudative CNVM lesions that may be missed on traditional imaging assessments.

The Short-term Treatment Efficacy of Intravitreal Ranibizumab Injection in Treatment-Naïve Patients with Diabetic Macular Edema

The Short-term Treatment Efficacy of Intravitreal Ranibizumab Injection in Treatment-Naïve Patients with Diabetic Macular Edema

Cost-Utility Analysis of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration

To quantify the cost-utility ratio of the ranibizumab Port Delivery System (PDS; SUSVIMO) versus intravitreal ranibizumab injections for treating neovascular age-related macular degeneration (nAMD) based upon Archway Phase 3 Trial data. Cost-utility analysis. Archway Phase 3 Clinical Trial nAMD participants previously responsive to anti-VEGF therapy were randomized 3:2. Two hundred forty received PDS refills q 24 weeks and 162 received ranibizumab injections. Ophthalmic patient, time tradeoff utilities, direct medical and societal cost perspectives, 12-year, 1-year, and 5-year timelines, United States 2022 real dollars, and a 3% annual discount rate were employed. Utilities were adjusted for nAMD conversion in fellow eyes during the 12-year, mean participant life expectancy. Premature death associated with severe vision loss was integrated as per the population-based Salisbury Eye Evaluation Study. Quality-adjusted life-year (QALY) accruals, costs, and incremental and average cost-utility ratios in $/QALY (dollars expended per QALY gained). Versus no therapy, the 1-year PDS QALY gain was 0.0156 (6.8%) versus 0.0063 (0.82%) for intravitreal injections (P < 0.001), whereas the respective 12-year QALY gains were 1.714 (28%) and 1.639 (26.8%) (P= 0.99). One-year direct PDS ophthalmic costs totaled $21 825 with 2 ranibizumab fills, whereas ranibizumab injection therapy totaled $18 405 with 11.8 injections. The 1-year incremental PDS $/QALY versus injections was cost effective at $75 497/QALY. Five-year PDS therapy was not incrementally cost effective at $304 108/QALY, nor was the 12-year therapy at $761 646/QALY. Average 12-year cost-utility ratios were $78773/QALY for the PDS and $47 917/QALY for injection therapy. Adding-$476 442 12-year offsetting societal costs netted $314 521 to society per PDS participant versus $370 958 per participant for injection therapy. Ranibizumab PDS therapy was not incrementally cost effective versus ranibizumab injection therapy at 12 or 5 years but was at 1 year. Injection therapy had a more favorable 12-year average cost-utility ratio. Vision gain was the major determinant of participant value gain and was the same for both interventions. Both interventions were highly cost effective utilizing average cost-utility analysis with the societal cost perspective. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Modified early intensive and treat-and-extend regimen of anti-vascular endothelial growth factor for diabetic macular edema in Taiwan

Given the rising prevalence of patients with diabetes and increasing treatment burden for patients with vision-threatening diabetic macular edema (DME), we aimed to explore the efficacy of modified early intensive and treat-and-extend regimen of anti-vascular endothelial growth factor (VEGF) therapy under the Taiwan National Insurance Bureau reimbursement policy. We obtained data on 69 eyes treated with initial 4-monthly intravitreal injections of aflibercept or ranibizumab, plus individualized treat-and-extend regimen. At 12 months, the mean (SD) change in LogMAR best corrected visual acuity from baseline was − 0.28 (0.31) in all eyes, while that in the aflibercept and ranibizumab groups were − 0.30 (0.34) and − 0.25 (0.28), respectively. Central retinal thickness decreased by 137.2 (122.4) in all eyes, 138.1 (134.2) in the aflibercept group, and 136.2 (110.9) in the ranibizumab group. Additionally, the aflibercept group had a lower mean number of injections than the ranibizumab group (8.5 vs. 8.7). The last extended dosing interval of > 12 weeks was 31.0% and 16.7% of the eyes in the aflibercept and ranibizumab groups, respectively. The modified anti-VEGF regimens effectively managed DME in terms of functional and anatomical outcomes, and efficiently reduced the healthcare burden by reducing the number of injections and extending treatment intervals within 12 months.