Publications by authors named "Joel Pearlman"
Purpose: Sozinibercept inhibits vascular endothelial growth factors (VEGFs) C and D. This study evaluated outcomes following switching from anti-VEGF-A monotherapy to intravitreal injections of three dose levels of sozinibercept in combination with aflibercept in patients with diabetic macular edema (DME).
Methods: A phase 1b, open-label, multicenter dose-escalation study with a 24-week follow-up.
Purpose: To evaluate the safety and tolerability of a single dose of axitinib injectable suspension (CLS-AX), a pan-anti-VEGF tyrosine kinase inhibitor (TKI), administered via suprachoroidal injection in patients with neovascular age-related macular degeneration (nAMD).
Design: Phase I/IIa, open-label, sequential dose escalation.
Participants: Anti-VEGF treatment-experienced patients with active subfoveal choroidal neovascularization secondary to nAMD.
Objective: To evaluate the efficacy, safety, and immunogenicity of a ranibizumab biosimilar candidate (XSB-001) versus reference product (Lucentis) for neovascular age-related macular degeneration (nAMD).
Design: Phase III, multicenter, randomized, double-masked, parallel-group study.
Participants: Patients with nAMD.
Private equity ownership of ophthalmology practices: how does it impact clinical research?
Curr Opin Ophthalmol
September 2022
Purpose Of Review: To explore the impact of private equity ownership of ophthalmology practices on the success of their clinical research programs.
Recent Findings: Private equity partnership in the clinical research space has been steadily occurring over the past decades. In addition to contract research organizations, private equity groups have also consolidated multiple independent clinical research networks.
Purpose: To analyze a series of eyes with brolucizumab-associated intraocular inflammation (IOI) without retinal vasculitis reported to the American Society of Retina Specialists (ASRS).
Methods: The ASRS Research and Safety in Therapeutics (ReST) Committee analyzed clinical characteristics from submitted reports of IOI after brolucizumab. Eyes with retinal vasculitis or that received intraocular antibiotics were excluded.
Article Synopsis
- The study aimed to evaluate the safety and efficacy of avacincaptad pegol (Zimura), a C5 inhibitor, in treating geographic atrophy (GA) related to age-related macular degeneration (AMD).
- It was a significant clinical trial (GATHER1) involving 286 participants, with results showing a 27-28% reduction in GA growth over 12 months for both dose groups compared to a sham group.
- The treatment was generally well tolerated, with no serious adverse events reported, leading to plans for a follow-up study (GATHER2) to further confirm its effectiveness and safety.
Purpose: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of brolucizumab for treatment of neovascular age-related macular degeneration.
Methods: The ASRS Research and Safety in Therapeutics Committee analyzed clinical and imaging characteristics from submitted reports of retinal vasculitis after brolucizumab.
Results: Retinal vasculitis was reported in 26 eyes of 25 patients (22 [88%] female) after treatment with brolucizumab.
Purpose: OPT-302 is a novel inhibitor of vascular endothelial growth factor (VEGF)-C and VEGF-D. A phase 1 trial assessed the safety of intravitreal OPT-302 as monotherapy or combined with ranibizumab (Lucentis; Genentech, South San Francisco, CA) in patients with neovascular age-related macular degeneration (nAMD).
Design: Open-label, dose escalation followed by a randomized dose expansion.
Purpose: To determine whether emixustat hydrochloride (emixustat) reduces the rate of enlargement of geographic atrophy (GA) compared with placebo in subjects with age-related macular degeneration (AMD) and to evaluate the safety and tolerability of emixustat over 24 months of treatment.
Design: Multicenter, randomized, double-masked, placebo-controlled, phase 2b/3 clinical trial.
Participants: Patients with GA secondary to AMD, a visual acuity score of at least 35 letters, and GA with a total area of 1.
Background: Noninvasive detection of Alzheimer's disease (AD) with high specificity and sensitivity can greatly facilitate identification of at-risk populations for earlier, more effective intervention. AD patients exhibit a myriad of retinal pathologies, including hallmark amyloid β-protein (Aβ) deposits.
Methods: Burden, distribution, cellular layer, and structure of retinal Aβ plaques were analyzed in flat mounts and cross sections of definite AD patients and controls (n = 37).
Purpose: To assess whether combination therapy (CT) reduces retreatments when compared to ranibizumab monotherapy (RM), while safely maintaining similar vision outcomes.
Methods: In this 24-month trial, patients with age-related macular degeneration (AMD) were randomized to 1) quarter-fluence or 2) half-fluence triple therapy (verteporfin photodynamic therapy [vPDT] + ranibizumab + dexamethasone), 3) half-fluence double therapy (vPDT + ranibizumab), or 4) RM. The primary outcomes were number of retreatment visits and change from baseline in visual acuity (VA) at 12 months.
Purpose: To assess the safety and efficacy of E10030 (Fovista; Ophthotech, New York, NY), a platelet-derived growth factor (PDGF) antagonist, administered in combination with the anti-vascular endothelial growth factor (VEGF) agent ranibizumab (Lucentis; Roche, Basel, Switzerland) compared with ranibizumab monotherapy in patients with neovascular age-related macular degeneration (nAMD).
Design: Phase IIb global, multicenter, randomized, prospective, double-masked, controlled superiority trial.
Participants: Four hundred forty-nine patients with treatment-naïve nAMD.
Purpose: To describe the progressive, peripheral linear streaks of the equatorial retina, known as Schlaegel lines, in multifocal choroiditis and panuveitis (MCP).
Methods: A case report of a 13-year-old girl with MCP showed progression of retinal linear streaks. Extensive systemic and ophthalmologic investigations were performed.
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.
Purpose: To report the biologic effect of intravitreal bevacizumab in patients with retinal and iris neovascularization secondary to diabetes mellitus.
Design: Interventional, consecutive, retrospective, case series.
Participants: Forty-five eyes of 32 patients with retinal and/or iris neovascularization secondary to diabetes mellitus.
Purpose: To determine the effect of pigment epithelium-derived factor (PEDF) in a mouse model of ischemia-induced retinal neovascularization and on vascular endothelial growth factor (VEGF)--induced migration and growth of cultured microvascular endothelial cells.
Methods: Human recombinant PEDF was expressed in the human embryonic kidney 293 cell line and purified by ammonium sulfate precipitation and cation exchange chromatography. C57BL/6 mice were exposed to 75% oxygen from postnatal day (P)7 to P12 and then returned to room air.