Publications by authors named "Nancy 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.
Development of a Consensus Guideline for the Diagnosis and Management of Chronic Noninfectious Uveitis Affecting the Posterior Segment.
Ophthalmic Surg Lasers Imaging Retina
November 2024
Background And Objective: A consensus exercise was carried out to address unmet needs in the classification, diagnosis, and management of patients with chronic noninfectious uveitis affecting the posterior segment (NIU-PS), with a focus on chronic postoperative inflammation/cystoid macular edema.
Methods: Eight experts participated in roundtable discussions and consensus-building exercises to develop clear guidelines for the diagnosis and management of chronic NIU-PS. The group addressed questions surrounding clinical features, diagnostic tests, and treatment considerations.
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: Diabetic Retinopathy Clinical Research Network Protocol T suggests that the response to treatment among patients with diabetic macular edema (DME) may vary depending on baseline best-corrected visual acuity (BCVA). We evaluated the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME and baseline BCVA of 20/50 or worse enrolled in faricimab phase III trials.
Design: YOSEMITE and RHINE were identically designed, multicenter, randomized, double-masked, active comparator-controlled, noninferiority trials.
Purpose: In diabetic macular edema (DME), hyper-reflective foci (HRF) has been linked to disease severity and progression. Using an automated approach, we aimed to investigate the baseline distribution of HRF in DME and their co-localization with cystoid intraretinal fluid (IRF).
Methods: Baseline spectral-domain optical coherence tomography (SD-OCT) volume scans (N = 1527) from phase III clinical trials YOSEMITE (NCT03622580) and RHINE (NCT03622593) were segmented using a deep-learning-based algorithm (developed using B-scans from BOULEVARD NCT02699450) to detect HRF.
Introduction: Understanding patient perspectives of treatment may improve adherence and outcomes. This study explored real-world patient experiences with anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD).
Methods: This multinational, non-interventional, quantitative, cross-sectional, observational survey assessed treatment barriers/burden, patient-reported visual functioning, and treatment satisfaction in DME and nAMD patients in the USA, the UK, Canada, France, Italy, and Spain.
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 evaluate disease progression and associated vision changes in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 eye and GA or neovascular AMD (nAMD) in the fellow eye using a large dataset from routine clinical practice.
Design: Retrospective analysis of clinical data over 24 months.
Subjects: A total of 256 635 patients with GA from the American Academy of Ophthalmology (Academy) IRIS® Registry (Intelligent Research in Sight) Registry (January 2016 to December 2017).
Purpose: To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe.
Methods: A 16-question online survey was created in English and distributed between Dec 01, 2021 and Jan 31, 2022. A total of 112 respondents (retinal physicians) from the US and Europe participated.
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).
Purpose: To assess treatment burden in patients with diabetic macular edema (DME) after the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN).
Design: Prospective and retrospective analyses of a 36-month, phase 4, open-label, observational study.
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.