Publications by authors named "Nancy M Holekamp"
Background: Geographic atrophy (GA) is an advanced form of age-related macular degeneration leading to irreversible vision loss and negative impacts on quality of life.
Methods: To assess the experiences of living with GA, the Geographic Atrophy Insights Survey (GAINS) was conducted between October 12, 2021, and December 10, 2021, captured the responses of individuals ≥60 years with a self-reported GA diagnosis residing in the United States, Canada, Australia, and six European countries. Survey questions focused on the perceptions of individuals living with GA and covered six themes: speed of disease progression, effect on independence, impact on quality of life, emotional toll of GA, misconceptions and need for further education about GA, and clinician interactions.
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). 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.
View Article and Find Full Text PDFPurpose: To provide a perspective on the management of neovascular age-related macular degeneration (nAMD) patients using a combination of sustained drug delivery strategies and remote monitoring technology.
Design: Evidence-based perspective METHODS: Review of the literature and experience of the author RESULTS: Currently there are many ongoing research efforts in the retina field directed at both safe, effective sustained drug delivery and validated remote monitoring. At present, the Port Delivery System with ranibizumab and the Home OCT are FDA approved and available for use by clinicians.
Purpose: To evaluate the impact of home optical coherence tomography (OCT)-guided patient management on treatment burden and visual outcomes.
Methods: An interventional trial was conducted to compare frequency of treatment and visual acuity for the neovascular age-related macular degeneration patients before and during use of home optical coherence tomography over a period of 6 months. Patient adherence to regular scanning was measured by the number of scans performed per week.
Introduction: Diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) require frequent anti-vascular endothelial growth factor (VEGF) treatment and monitoring visits. We aimed to understand the burden of treatment on caregivers.
Methods: This multinational, noninterventional study used a cross-sectional survey of adult patients with DME or nAMD treated with anti-VEGF injections in the USA, Canada, France, Italy, Spain, and the UK.
Article Synopsis
- - The study aimed to compare the types and rates of complications from the Port Delivery System (PDS) with other ocular implants that cross the sclera, focusing on long-term safety from clinical trials and real-world data.
- - A systematic literature review found reports from 16 clinical trials and 43 real-world studies, which detailed 30 complications associated with various ocular implants, highlighting a generally acceptable safety profile.
- - The rates of specific complications for the PDS were consistent with those of other ocular devices, suggesting similar long-term safety across these implant systems in ophthalmology.
Purpose: To determine the proportion and characteristics of eyes with neovascular age-related macular degeneration (nAMD) treated with the Port Delivery System (PDS) with ranibizumab that receive supplemental intravitreal ranibizumab injections because of changes in best-corrected visual acuity (BCVA) or central subfield thickness (CST), or both, and to investigate the safety and efficacy of supplemental injections in eyes with the PDS.
Design: Post hoc analyses of data from the phase III, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934).
Participants: Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-VEGF therapy.
Purpose: To develop professional guidelines for best practices for suprachoroidal space (SCS) injection, an innovative technique for retinal therapeutic delivery, based on current published evidence and clinical experience.
Methods: A panel of expert ophthalmologists reviewed current published evidence and clinical experience during a live working group meeting to define points of consensus and key clinical considerations to inform the development of guidelines for in-office SCS injection.
Results: Core consensus guidelines for in-office SCS injection were reached and reported by the expert panel.
Introduction: A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the comparative efficacy, durability and safety of faricimab, used in a Treat & Extend (T&E) regime with intervals up to every 16 weeks (Q16W), relative to other therapies currently in use for treatment of diabetic macular oedema (DME). Of particular interest were anti-vascular endothelial growth factor (VEGF) therapies applied in flexible dosing regimens such as Pro re nata (PRN) and T&E, which are the mainstay in clinical practice.
Methods: An SLR identifying randomised controlled trials (RCTs) published before August 2021 was conducted, followed by a Bayesian NMA comparing faricimab T&E treatment to aflibercept, ranibizumab, bevacizumab, dexamethasone and laser therapy.
Purpose: To establish the safety, tolerability, pharmacokinetics, and pharmacodynamics of an intravitreal injection of recombinant human complement factor H (CFH), GEM103, in individuals with genetically defined age-related macular degeneration (AMD) and geographic atrophy (GA).
Design: Phase I single ascending-dose, open-label clinical trial (ClinicalTrials.gov identifier, NCT04246866).
Relationship between retinal fluid characteristics and vision in neovascular age-related macular degeneration: HARBOR post hoc analysis.
Graefes Arch Clin Exp Ophthalmol
December 2022
Purpose: To evaluate the relationship between retinal fluid location, amount/severity, and vision with ranibizumab-treated neovascular age-related macular degeneration (nAMD).
Methods: In the phase 3 HARBOR trial (NCT00891735), treatment-naive patients with nAMD received ranibizumab 0.5 or 2.
Drivers of and Barriers to Adherence to Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema Treatment Management Plans: A Multi-National Qualitative Study.
Patient Prefer Adherence
March 2022
Article Synopsis
- The study investigates the real-world experiences of patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) undergoing anti-VEGF treatment, finding that these patients often have lower vision improvements than those in clinical trials.
- Interviews with 49 nAMD and 46 DME patients, along with their caregivers and retina specialists, revealed that routine disruptions, missed appointments, and treatment adherence are influenced by various factors, especially the doctor-patient relationship.
- Key barriers to treatment adherence included reported side effects primarily affecting patients and caregivers, while logistical issues, like travel, were the main concern for retina specialists, showcasing the complexity of managing these conditions in a real-world setting.*
Objective: To validate the performance of the Notal Vision Home OCT (NVHO) system for daily self-imaging at home and characterize the retinal fluid dynamics of patients with neovascular age-related macular degeneration (nAMD).
Design: Prospective observational study.
Subjects: Fifteen participants who had at least 1 eye with nAMD and underwent anti-VEGF treatments.
Purpose: To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).
Design: Phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial.
Participants: Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy.
Purpose: To investigate the relationship between retinal fluid and vision in ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD).
Design: Clinical cohort study using post hoc analysis of clinical trial data.
Methods: We assessed data from HARBOR (NCT00891735), a phase III, randomized, controlled trial.
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.
View Article and Find Full Text PDFPurpose: We discuss a peripheral combined hamartoma of the retina and retinal pigment epithelium (CHRRPE) with a macula-involving TRD that was repaired by vitrectomy surgery.
Methods: A case report is presented.
Results: A 15-year-old white girl with no significant medical or ocular history presented to the retina clinic with a 1-month history of progressive loss of inferior visual field in the right eye.
Background: The 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO.
View Article and Find Full Text PDFDue to an aging population, visual impairment from neovascular age-related macular degeneration (nAMD) is increasing in the United States. Despite unprecedented improvements in vision preservation that patients can achieve with anti-vascular endothelial growth factor (VEGF) agents, innovations are needed to reduce the burden of intravitreal injections and improve outcomes in patients who do not respond adequately to currently available agents. The best present option for vision preservation is a "zero-tolerance for fluid" schedule of monitoring and intravitreal injections that patients may need to follow for many years.
View Article and Find Full Text PDFBackground/objectives: This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
Subjects/methods: Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
Purpose: To determine monitoring and treatment patterns and vision outcomes in real-world patients initiating anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME).
Design: Retrospective interventional cohort study.
Methods: Setting: Electronic medical record analysis of Geisinger Health System data.
Purpose: This post hoc analysis explores the relationship between early retinal anatomical response and long-term anatomical and visual outcomes with ranibizumab in center-involved diabetic macular edema.
Methods: Eyes randomized to the ranibizumab plus prompt laser and ranibizumab plus deferred laser treatment arms in the Protocol I study were categorized according to their proportional reduction (<20 vs. ≥20%) in central retinal thickness (CRT) after 12 weeks.