Refillable Drug Reservoirs for Retinal Vascular Diseases.

Purpose: Most patients with retinal vascular disease require chronic, regular treatments to maximize visual potential. This places a challenging burden on the patient and is one reason why real-world visual outcomes often lag the results seen in clinical trials.

Methods: Sustained drug delivery devices have long been considered one way to alleviate this difficulty.

Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections.

Purpose: To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.

Design: Post hoc analyses of phase 3 Archway trial (NCT03677934).

Participants: Adults with nAMD responsive to anti-VEGF therapy.

Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration.

Objective: The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration (nAMD). Portal (NCT03683251) is evaluating long-term safety and tolerability of the PDS in patients with nAMD who completed the phase II Ladder (NCT02510794) or phase III Archway (NCT03677934) trials.

Design: Multicenter, nonrandomized, open-label, extension clinical trial.

Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development.

Purpose: The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration. The United States Prescribing Information has a Boxed Warning for endophthalmitis and reports the incidence rate in patients developing endophthalmitis after receiving the PDS compared with monthly intravitreal ranibizumab. Endophthalmitis cases noted in the Boxed Warning, treatment outcomes, potential contributing factors, and potential mitigations are summarized.

Exudation in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System or Monthly Injections.

Purpose: To evaluate for the presence, severity, and type of exudation at each study visit for a subgroup of patients with neovascular age-related macular degeneration from the Archway and Portal trials.

Design: Retrospective analysis of prospectively obtained data.

Methods: Spectral-domain optical coherence tomography scans from each study visit of 44 patients from the Port Delivery System (PDS) arm and 32 patients from the monthly injection arm of Archway were evaluated, and composites of horizontal scans through the fovea were created.

Prevalence of Macular Atrophy in the MARINA Study of Ranibizumab versus Sham for Neovascular Age-Related Macular Degeneration.

Objective: Determine prevalence, progression rates, and associations of newly detectable macular atrophy (MA) in patients with choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration (nAMD) with/without ranibizumab treatment.

Design: Post hoc analysis of MA in patients with occult/minimally classic nAMD who received monthly intravitreal ranibizumab (0.3 or 0.

Implantation Site of a Port Delivery System With Ranibizumab: Anterior Segment Optical Coherence Tomography Evaluation.

To determine whether anterior segment optical coherence tomography (AS-OCT) can be used to obtain noninvasive high-resolution images for monitoring the implantation site of a port delivery system with ranibizumab (PDS). Six eyes from the Archway phase 3 trial were imaged with AS-OCT after surgical implantation of the PDS and at regular follow-up visits. AS-OCT was helpful in monitoring the status of the overlying conjunctiva and Tenon capsule after implantation of the PDS.

Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results.

Purpose: To report 2-year results from the Archway clinical trial of the Port Delivery System with ranibizumab (PDS) for treatment of neovascular age-related macular degeneration (nAMD).

Design: Phase 3, randomized, multicenter, open-label, active-comparator-controlled trial.

Participants: Patients with previously treated nAMD diagnosed within 9 months of screening and responsive to anti-vascular endothelial growth factor therapy.

Characteristics that Correlate with Macular Atrophy in Ranibizumab-Treated Patients with Neovascular Age-Related Macular Degeneration.

Objective: To use multimodal assessment (fluorescein angiography [FA], color fundus photography [CFP], and spectral-domain-OCT [SD-OCT]) to reevaluate macular atrophy (MA) and macular neovascularization (MNV) type in the HARBOR trial according to the consensus on neovascular age-related macular degeneration (nAMD) Nomenclature criteria; and to determine if there are any associations between baseline demographic factors, ocular characteristics, and treatment for nAMD and the development of MA by month 24.

Design: Post hoc analysis of the phase III, randomized, multicenter, double-masked, controlled HARBOR trial (NCT00891735).

Subjects: Nine-hundred and twenty-two study eyes and 919 fellow eyes from the HARBOR trial.

Pharmacokinetics of the Port Delivery System with Ranibizumab in the Ladder Phase 2 Trial for Neovascular Age-Related Macular Degeneration.

Introduction: Ladder was a phase 2 trial that evaluated the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration. Serum and aqueous humor samples were collected to characterize the pharmacokinetics (PK) of ranibizumab delivered through the PDS.

Methods: Ladder was a multicenter, randomized, active treatment-controlled, phase 2 clinical trial.

Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.

Importance: The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.

Objective: Evaluate treatment satisfaction for ranibizumab delivered via PDS vs intravitreal injections as well as patient preference among those assigned to PDS.

Design, Setting, And Participants: Archway was a phase 3 randomized active-comparator open-label clinical trial conducted at 78 sites in the US.

Relationship between retinal fluid characteristics and vision in neovascular age-related macular degeneration: HARBOR post hoc analysis.

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.

Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab.

Purpose: To provide strategies for the management of key ocular adverse events (AEs) that may be encountered with the Port Delivery System with ranibizumab (PDS) in practice and provide recommendations that may mitigate such AEs based on clinical trial experiences and considerations from experts in the field.

Design: Safety evaluation based on the phase 2 Ladder (NCT02510794) and phase 3 Archway (NCT03677934) trials of the PDS.

Methods: The PDS implant is a permanent, indwelling, and refillable ocular drug delivery system that requires standardized procedural steps for its insertion and refill-exchange procedures, which evolved during the PDS clinical program.

Implant Insertion Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Pearls.

Objective: To describe the Port Delivery System with ranibizumab implant insertion procedure.

Methods: A surgical procedure based on the clinical trial program in patients with retinal diseases.

Results: An infusion line is placed in the infero-temporal quadrant; a superotemporal quadrant corneal traction suture is recommended.

Prevalence and Progression of Macular Atrophy in Eyes with Neovascular Age-Related Macular Degeneration in the Phase 2 Ladder Trial of the Port Delivery System with Ranibizumab.

Purpose: To determine whether the rates of macular atrophy (MA) differ between eyes with neovascular age-related macular degeneration (nAMD) treated continuously with the Port Delivery System with ranibizumab (PDS) and those treated with ranibizumab given as a bolus intravitreal injection.

Design: A preplanned exploratory analysis of a phase 2, multicenter, randomized, active treatment-controlled, dose-ranging study.

Participants: Patients diagnosed with nAMD within 9 months of screening who had received at least 2 previous intravitreal anti-vascular endothelial growth factor injections of any agent and were responsive to the treatment.

Fluctuations in central foveal thickness and association with vision outcomes with anti-VEGF therapy for nAMD: HARBOR post hoc analysis.

Objective: To evaluate correlations between variability in central foveal thickness (CFT) and vision with ranibizumab in a HARBOR post hoc analysis.

Methods And Analysis: Patients with neovascular age-related macular degeneration (nAMD; N=1097) received monthly or as-needed (PRN) ranibizumab (0.5 or 2.

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR.

Purpose: To characterize relationships between Consensus on Neovascular Age-Related Macular Degeneration Nomenclature (CONAN) Study Group classifications of macular neovascularization (MNV) and visual responses to ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

Methods: This was a post hoc analysis of the phase 3 HARBOR trial of ranibizumab in nAMD. Analyses included ranibizumab-treated eyes with baseline multimodal imaging data; baseline MNV; subretinal and/or intraretinal fluid at screening, baseline, or week 1; and spectral-domain optical coherence tomography images through month 24 (n = 700).

Effect of Residual Retinal Fluid on Visual Function in Ranibizumab-Treated Neovascular Age-Related Macular Degeneration.

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.

End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration.

Purpose: To report the end-of-study results from the Ladder clinical trial of the Port Delivery System with ranibizumab (PDS) for the treatment of neovascular age-related macular degeneration (nAMD).

Design: Multicenter, randomized, active treatment-controlled phase 2 clinical trial.

Participants: Patients diagnosed with nAMD with a documented response to anti-vascular endothelial growth factor treatment who received study treatment (N = 220).

Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration.

Purpose: To identify baseline risk factors for macular atrophy (MA) development in HARBOR via a longitudinal assessment of monthly spectral-domain (SD)-OCT scans. Previous analyses of MA in HARBOR examined data from color fundus photography (CFP) and fluorescein angiography (FA).

Design: Retrospective, post hoc analysis of SD-OCT images from HARBOR (ClinicalTrials.

Agreement of Spectral-Domain OCT with Fluorescein Leakage in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.

Purpose: To evaluate the agreement between detection of activity of choroidal neovascularization (CNV) in neovascular age-related macular degeneration (AMD) by fundus fluorescein angiography (FFA) and spectral-domain (SD) OCT in the HARBOR study. Most retina specialists rely on OCT to guide treatment decisions in neovascular AMD. However, OCT may not always detect exudative activity.

Long-Term Vision Outcomes in Patients With DME and a Limited Early Visual Response to Ranibizumab in RIDE and RISE.

Background And Objective: To compare early and long-term visual responses to ranibizumab in patients with diabetic macular edema.

Patients And Methods: Retrospective analysis of RIDE (NCT00473382) and RISE (NCT00473330). Vision outcomes over 36 months were compared between limited early gainers (gained ≤ 5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters), early 1-line gainers (gained 6 to 9 ETDRS letters), and early 2-or-more-line gainers (gained ≥ 10 ETDRS letters) at Month 3.

MACULAR ATROPHY IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Pilot Post Hoc Analysis of Patients With Pigment Epithelial Detachments.

Purpose: To determine optical coherence tomography signs associated with macular atrophy (MA) in eyes with neovascular age-related macular degeneration and pigment epithelial detachments treated with vascular endothelial growth factor inhibitors.

Methods: Optical coherence tomography scans from a subgroup of the pigment epithelial detachment cohort of the HARBOR study were analyzed for MA. Two groups were formed based on MA presence/absence at Month 24.

Spectral-Domain OCT-Based Prevalence and Progression of Macular Atrophy in the HARBOR Study for Neovascular Age-Related Macular Degeneration.

Purpose: Previous studies of macular atrophy (MA) in HARBOR analyzed color fundus photography and fluorescein angiography image data. This study performed a longitudinal assessment of monthly spectral-domain (SD) OCT scans to determine MA prevalence, incidence, and progression in HARBOR.

Design: Post hoc analysis of SD OCT images from HARBOR (ClincalTrials.

Microperimetry for geographic atrophy secondary to age-related macular degeneration.

Geographic atrophy (GA) is a progressive, advanced form of age-related macular degeneration leading to visual function impairment and irreversible vision loss. Standard clinical tests to evaluate visual function in patients with GA provide poor anatomic-functional correlation, whereas fundus imaging does not assess the visual function deficit. Microperimetry is a psychophysical visual function test that spatially maps retinal sensitivity and allows for identification of correlation of anatomic features with visual function.