Publications by authors named "Dennis M Marcus"
: To evaluate the clinical performance of two optical coherence tomography angiography (OCTA) devices, including a semi-automated device, with respect to image quality and pathology detection, with fluorescein angiography (FA) and indocyanine green angiography (ICGA) serving as the reference standards. : In this prospective cross-sectional study, normal eyes and those with various retinal and choroidal pathologies were enrolled and underwent OCTA scanning using semi-automated 3D OCT-1 Maestro2 and Cirrus™ HD-OCT 5000 devices, as well as FA/ICGA imaging. OCTA scans and FA/ICGA images were independently graded for image quality and the visibility of prespecified anatomic vascular features, along with the presence or absence of pathology on the OCTA scans and the FA/ICGA images (within regions corresponding to the OCTA scan areas).
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- Biosimilars like MYL-1701P, a version of aflibercept, offer potentially cheaper options for treating diabetic macular edema (DME), but their efficacy and safety compared to the original have not been fully studied.
- A randomized double-masked trial across multiple countries involved 355 participants with DME to compare MYL-1701P and aflibercept, focusing on vision improvement and side effects over a year.
- Results showed similar improvements in visual acuity between the two treatments after 8 weeks, with MYL-1701P achieving an adjusted mean difference of just 0.04 letters from aflibercept, indicating comparable effectiveness.
Complications, Compliance, and 3-Year Outcomes After Endolaserless Vitrectomy With Aflibercept Monotherapy for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage.
Ophthalmic Surg Lasers Imaging Retina
February 2023
Background And Objective: To report the 3-year outcomes for endolaserless vitrectomy with intravitreal aflibercept injection (IAI) monotherapy for proliferative diabetic retinopathy (PDR)-related vitreous hemorrhage (VH).
Materials And Method: Eyes underwent endolaserless vitrectomy and received one preoperative and intraoperative IAI followed by randomization to a q8week or q16week IAI group. Additional IAI was administered as needed.
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).
Importance: Presence of predominantly peripheral diabetic retinopathy (DR) lesions on ultra-widefield fluorescein angiography (UWF-FA) was associated with greater risk of DR worsening or treatment over 4 years. Whether baseline retinal nonperfusion assessment is additionally predictive of DR disease worsening is unclear.
Objective: To assess whether the extent and location of retinal nonperfusion identified on UWF-FA are associated with worsening in Diabetic Retinopathy Severity Scale (DRSS) score or DR treatment over time.
Article Synopsis
- Ultra-widefield (UWF) imaging is more effective at finding peripheral diabetic retinopathy (DR) lesions compared to standard imaging techniques, but it remains unclear if these lesions can predict worsening disease.
- A cohort study involving 388 participants across 37 sites was conducted to investigate if predominantly peripheral lesions (PPLs) detected by UWF imaging are linked to an increased risk of disease worsening, beyond what is indicated by initial DR severity scores.
- After analyzing data from 544 study eyes, findings showed that rates of disease worsening varied by the severity of nonproliferative diabetic retinopathy (NPDR), but the presence of color PPL at baseline did not significantly predict worsening outcomes.
Background: In eyes with diabetic macular edema, the relative efficacy of administering aflibercept monotherapy as compared with bevacizumab first with a switch to aflibercept if the eye condition does not improve sufficiently (a form of step therapy) is unclear.
Methods: At 54 clinical sites, we randomly assigned eyes in adults who had diabetic macular edema involving the macular center and a visual-acuity letter score of 24 to 69 (on a scale from 0 to 100, with higher scores indicating better visual acuity; Snellen equivalent, 20/320 to 20/50) to receive either 2.0 mg of intravitreous aflibercept or 1.
Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience.
Ophthalmic Surg Lasers Imaging Retina
May 2022
Purpose: To describe the Port Delivery System with ranibizumab refill-exchange procedure.
Methods: Procedure based on the clinical trial program in patients with retinal diseases.
Results: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions.
Study Objectives: To determine if obstructive sleep apnea syndrome (OSAS) predisposes patients to glaucoma and macular disease due to vascular compromise by evaluating retinal and optic nerve vasculature and function using optical coherence tomography angiography and Humphrey visual field testing, respectively.
Methods: In this prospective, observational, cross-sectional study 45 patients undergoing polysomnography ordered per standard of care were selected and stratified based on apnea-hypopnea index (AHI). Medical history, visual acuity testing, 24-2 Humphrey visual field, intraocular pressure measurement, and optical coherence tomography angiography studies of the macular and peripapillary retina were obtained.
Importance: The role of anti-vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established.
Objective: To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR.
Design, Setting, And Participants: Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME.
Purpose: To evaluate the safety and efficacy of the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) treatment.
Design: Phase 2, multicenter, randomized, active treatment-controlled clinical trial.
Participants: Patients diagnosed with nAMD within 9 months who had received 2 or more prior anti-vascular endothelial growth factor intravitreal injections and were responsive to treatment.
Importance: Identifying the factors that are associated with the magnitude of treatment benefits from anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME) may help refine treatment expectations.
Objective: To identify the baseline factors that are associated with vision and anatomic outcomes when managing DME with anti-VEGF and determine if there are interactions between factors and the agent administered.
Design, Setting, And Participants: This post hoc analysis of data from the Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial , Protocol T, was conducted between December 2016 and December 2017.
Importance: Studies have established the efficacy and safety of aflibercept for the treatment of macular edema due to central retinal vein occlusion. Bevacizumab is used off-label to treat this condition despite the absence of supporting data.
Objective: To investigate whether bevacizumab is noninferior to aflibercept for the treatment of macular edema secondary to central retinal or hemiretinal vein occlusion.
Purpose: To evaluate intravitreal aflibercept injection (IAI) in patients with presumed ocular histoplasmosis syndrome and choroidal neovascularization.
Methods: Open-label randomized Phase I/II study of IAI in patients with presumed ocular histoplasmosis syndrome-related choroidal neovascularization. Thirty-nine eyes from 39 patients were randomized in a 1:1 ratio to 2 groups.
Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy in a Predominantly Non-Asian Population: RIVAL Results.
Ophthalmic Surg Lasers Imaging Retina
January 2017
Background And Objective: To evaluate safety and efficacy of intravitreal aflibercept (Eylea; Regeneron, Tarrytown, NY) injection (IAI) for the treatment of neovascular polypoidal choroidal vasculopathy (PCV) in a predominantly non-Asian population.
Patients And Methods: This was an open-label, prospective, unmasked, nonrandomized clinical trial. Twenty eyes with neovascular PCV received monthly 2.
Importance: Information on the effect of anti-vascular endothelial growth factor therapy in eyes with diabetic macular edema (DME) with vision loss after macular laser photocoagulation is clinically valuable.
Objective: To evaluate visual and anatomic outcomes in a subgroup of macular laser photocoagulation treatment control (hereafter laser control) eyes with substantial vision loss receiving treatment with intravitreal aflibercept injection.
Design, Setting, And Participants: This investigation was a post hoc analysis of a subgroup of laser control eyes in 2 phase 3 trials-VISTA (Study of Intravitreal Aflibercept Injection in Patients With Diabetic Macular Edema) and VIVID (Intravitreal Aflibercept Injection in Vision Impairment Due to DME)-in a multicenter setting.
Ranibizumab 0.3 mg for Persistent Diabetic Macular Edema After Recent, Frequent, and Chronic Bevacizumab: The ROTATE Trial.
Ophthalmic Surg Lasers Imaging Retina
November 2016
Background And Objective: To evaluate the safety and efficacy of 0.3 mg ranibizumab (Lucentis; Genentech, South San Francisco, CA) in eyes with persistent diabetic macular edema (DME) after recent, chronic, and frequent bevacizumab (Avastin; Genentech, South San Francisco, CA).
Patients And Methods: Open-label, prospective study of 0.
Purpose: To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years.
Design: Two similarly designed phase 3 trials: VISTA and VIVID.
Participants: Patients (eyes; n = 872) with central-involved DME.
Importance: Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME).
Objective: To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy.
Purpose: To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME).
Design: Two similarly designed, randomized, phase 3 trials, VISTA(DME) and VIVID(DME).
Participants: Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement.
Purpose: To evaluate retinal sensitivity in patients with diabetic macular edema who received intravitreal aflibercept injection (IAI) or laser.
Methods: A substudy included 46 patients from DA VINCI (a randomized, double-masked Phase 2 study) receiving either laser, 0.5 mg IAI every 4 weeks, 2 mg IAI every 4 weeks, 2 mg IAI every 8 weeks after 3 monthly doses (2q8), or 2 mg IAI as-needed after 3 monthly doses for 52 weeks.
Purpose: A head-to-head comparison was performed between vascular endothelial growth factor blockade and laser for treatment of diabetic macular edema (DME).
Design: Two similarly designed, double-masked, randomized, phase 3 trials, VISTA(DME) and VIVID(DME).
Participants: We included 872 patients (eyes) with type 1 or 2 diabetes mellitus who presented with DME with central involvement.
Objective: To determine long-term outcomes of patients with ranibizumab-treated retinal vein occlusion (RVO).
Design: Prospective follow-up of a subset of patients from 2 phase 3 trials.
Participants: Thirty-four patients with branch RVO (BRVO) and 32 with central RVO (CRVO) who completed the Genentech-sponsored ranibizumab study RVO trials.