Publications by authors named "Glenn Jaffe"
Article Synopsis
- The study aims to evaluate how functional and structural assessments can serve as endpoints in clinical trials for retinal degeneration linked to USH2A mutations.
- Participants with specific visual capabilities underwent various eye tests over four years, focusing on understanding changes in their vision.
- Findings indicated that certain tests were more sensitive to detecting changes, influencing the design of future clinical trials related to this condition.
Purpose: To report the safety and efficacy of brolucizumab (Beovu) 6 mg versus aflibercept (Eylea) 2 mg administered every 4 weeks in participants with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid after the week 52 up to week 104.
Design: Multicenter, randomized, double-masked phase 3a study.
Participants: Participants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-VEGF treatment).
Oxidative stress-mediated retinal pigment epithelial (RPE) cell damage is associated with age-related macular degeneration (AMD). ST266 is the biological secretome produced by a novel population of amnion-derived multipotent progenitor cells. Herein, we investigated the effect of ST266 on RPE cell injury induced by hydroquinone (HQ), a cigarette smoke related oxidant, hydrogen peroxide (HO) and all-trans retinal (atRal), a pro-oxidant component of the retinoid cycle.
View Article and Find Full Text PDFArticle Synopsis
- The study compared fundus autofluorescence (FAF) and optical coherence tomography (OCT) measurements of geographic atrophy (GA) to evaluate the effectiveness of avacincaptad pegol (ACP) treatment in a clinical trial called GATHER1.
- A post hoc analysis showed a strong correlation (r = 0.93) between FAF and OCT measurements, indicating that both methods provided similar results in assessing GA area.
- The OCT showed a significant reduction in GA growth between ACP and sham groups at 12 and 18 months, confirming that OCT can be a reliable method for measuring GA in clinical settings.
Background: Frequent anti-vascular endothelial growth factor A (VEGF-A) injections reduce the risk of rapid and severe vision loss in patients with neovascular age-related macular degeneration (nAMD); however, due to undertreatment, many patients lose vision over time. New treatments that provide sustained suppression of VEGF-A are needed. RGX-314 (currently known as ABBV-RGX-314) is an adeno-associated virus serotype 8 vector that expresses an anti-VEGF-A antigen-binding fragment, which provides potential for continuous VEGF-A suppression after a single subretinal injection.
View Article and Find Full Text PDFArticle Synopsis
- - The synopsis covers two studies, GATHER1 (2021) and GATHER2 (2023), focusing on the impact of avacincaptad pegol (ACP) on adult participants with geographic atrophy (GA), an advanced form of dry age-related macular degeneration.
- - Findings from both studies indicated that ACP can slow the progression of GA compared to a sham injection, with similar reading abilities maintained after one year of treatment.
- - While ACP shows promise as a potential treatment for GA, further research is necessary to determine its effectiveness and safety, and patients should consult their doctors before making any treatment decisions.
To analyze post-marketing cases of retinal vasculitis after intravitreal pegcetacoplan. The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee as well as an expert panel performed a retrospective review of cases of retinal vasculitis reported to the ASRS. Clinical and imaging characteristics were reviewed for evidence of retinal vasculitis and analyzed.
View Article and Find Full Text PDFPurpose: To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME).
Design: Randomized, double-masked, noninferiority phase 3 trials.
Purpose: The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System.
Methods: LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months.
Purpose: The aim of this analysis was to characterize the spectrum of inflammatory changes arising from brolucizumab use in routine clinical practice.
Design: Retrospective analysis of fluorescein angiography (FA), fundus photography (FP) and OCT images taken at the time of adverse event.
Subjects: Brolucizumab-treated patients with neovascular age-related macular degeneration with retinal vasculitis (RV) and/or retinal vascular occlusion (RO) reported to Novartis Patient Safety between February 2020 and January 2021.
Objective: To validate GATHER-1 inclusion criteria and the study's primary anatomic end point by assessing the reproducibility of geographic atrophy (GA) measurements and factors that affect reproducibility.
Design: Post hoc analysis of phase II/III clinical trial.
Subjects: All 286 participants included in the GATHER-1 study.
Purpose: To describe a case of bilateral panuveitis in an 11-year-old girl with autoimmune lymphoproliferative syndrome (ALPS) due to haploinsufficiency.
Case Description: A 5-year-old girl developed cervical adenopathy, and autoimmune hemolytic anemia and thrombocytopenia consistent with Evan's Syndrome. She was subsequently diagnosed with autosomal dominant haploinsuffciency and treated with immunosuppressants.
Article Synopsis
- Geographic atrophy is a severe type of dry age-related macular degeneration that can cause significant vision loss, and this study evaluates the safety and effectiveness of avacincaptad pegol 2 mg in slowing its progression.
- The GATHER2 trial was a comprehensive, double-masked, sham-controlled study conducted over 24 months, involving 448 participants aged 50 and older, divided into two groups receiving either the treatment or a sham injection.
- Results showed a significant reduction in the growth of geographic atrophy lesions in patients receiving avacincaptad pegol compared to those who received the sham treatment over 12 months.
Purpose: The purpose of this study was to report a case of Pseudomonas aeruginosa endophthalmitis after surgical 0.59 mg fluocinolone acetonide implant in a patient with a long-standing Crawford tube.
Methods: This was a retrospective case review.
Article Synopsis
- The HAWK and HARRIER studies focused on comparing the effectiveness and safety of brolucizumab and aflibercept for treating neovascular age-related macular degeneration in patients who had not been treated before.
- A post hoc analysis was conducted on pooled data to assess disease activity in eyes treated with brolucizumab versus aflibercept during the first year, specifically looking at various assessment weeks.
- Results showed that brolucizumab-treated eyes had a lower incidence of disease activity and less fluid compared to aflibercept, suggesting better fluid resolution and potential for extending treatment intervals in the first year.
Purpose: To determine the interreader agreement for reticular pseudodrusen (RPD) assessment on combined infrared reflectance (IR) and OCT imaging in the early stages of age-related macular degeneration across a range of different criteria to define their presence.
Design: Interreader agreement study.
Participants: Twelve readers from 6 reading centers.
Article Synopsis
- A 37-year-old woman with recurring eye inflammation after a fluocinolone acetonide implant exchange developed primary vitreoretinal lymphoma (PVRL), which initially presented as postoperative endophthalmitis.
- * She was previously treated with adalimumab for idiopathic bilateral panuveitis and experienced worsening symptoms despite treatment.
- * The case suggests a possible link between adalimumab therapy and the development of PVRL, highlighting the need for further investigation into this relationship.
Purpose: To develop a fully-automatic hybrid algorithm to jointly segment and quantify biomarkers of polypoidal choroidal vasculopathy (PCV) on indocyanine green angiography (ICGA) and spectral domain-OCT (SD-OCT) images.
Design: Evaluation of diagnostic test or technology.
Participants: Seventy-two participants with PCV enrolled in clinical studies at Singapore National Eye Center.
Article Synopsis
- The study investigated the safety and effectiveness of avacincaptad pegol (ACP), a C5 inhibitor, for treating geographic atrophy (GA) related to age-related macular degeneration (AMD) over an 18-month period.
- In a phase 2/3 clinical trial, 286 participants were split into groups to receive monthly injections of either ACP at different dosages or sham treatment, measuring GA progression with fundus autofluorescence.
- Results indicated that both ACP dosages significantly reduced GA growth compared to sham treatment, with mostly mild adverse effects; ongoing research (GATHER2 trial) is planned to further assess ACP's treatment potential.
Purpose: To develop a severity classification for macular telangiectasia type 2 (MacTel) disease using multimodal imaging.
Design: An algorithm was used on data from a prospective natural history study of MacTel for classification development.
Subjects: A total of 1733 participants enrolled in an international natural history study of MacTel.
Objective: To predict 2-year visual acuity (VA) responses to anti-VEGF therapy, using early morphologic and functional responses in patients with neovascular age-related macular degeneration (nAMD).
Design: Cohort within a randomized clinical trial.
Participants: A total of 1185 participants with untreated active nAMD and best-corrected visual acuity (BCVA) 20/25 to 20/320 at baseline.
Purpose: To report the outcomes of the 0.18 mg fluocinolone acetonide insert (FAi) in the treatment of chronic (>6 months) postoperative cystoid macular edema after cataract surgery.
Methods: This was a retrospective consecutive case series of eyes with chronic postoperative cystoid macular edema treated with the FAi.