Ophthalmology

PULSAR

A Phase III study of Aflibercept 8mg in nAMD

PULSAR is a global, phase III study investigating the efficacy and safety of aflibercept 8mg with extended dosing intervals in treatment-naïve patients with neovascular age-related macular degeneration

See PULSAR study design and results

See latest PULSAR extension results

PULSAR Study Design

Outcomes

Primary Outcome
• Change in baseline BCVA measured by the ETDRS letter score at Week 48
Secondary Outcomes
• Proportion of patients with no fluid, defined as no intraretinal fluid and subretinal fluid, in the centre subfield at week 16
• Proportion of patients gaining at least 15 letters in BCVA at week 48 from baseline
• Proportion of patients gaining an ETDRS letter score of at least 69 at week 48, the change in choroidal neovascularisation size from baseline to week 48
• Change in total lesion area from baseline to week 48
• Proportion of patients with no intraretinal fluid and subretinal fluid in the centre subfield at week 48, the change from baseline in CRT at week 48
• Change in NEI VFQ-25 total score at week 48 from baseline
Exploratory Endpoint:
• The proportion of patients randomised to aflibercept 8q12 or 8q16 who maintained 12-week or 16-week dosing intervals up to week 48, respectively
Safety Endpoint:
• Incidence of ocular and non-ocular TEAEs and serious TEAEs up to week 48

Criteria

Inclusion Criteria
• Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
• Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
• BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
• Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
• Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
• Other protocol-specified inclusion criteria.
Additional inclusion criteria for Year 3:
• At least one BCVA value and one CST value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
• Participant is enrolled at a site that participates in the extension period.
Exclusion Criteria
• Causes of CNV other than nAMD in the study eye.
• Scar, fibrosis, or atrophy involving the central subfield in the study eye.
• Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
• Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
• History of idiopathic or autoimmune uveitis in the study eye.
• Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
• Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
• Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
• Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.

NOTE: Other protocol-specified inclusion/exclusion criteria apply

Footnotes
_{^aTo be eligible for the Extension phase, patients had to have ≥1 BCVA and CRT assessments between Week 84 and Week 92.}

_{BCVA, best-corrected visual acuity; CNV, chorodial neovascularization; CRT, central retinal thickness; ETDRS, early treatment diabetic retinopathy study; IOP, intraocular pressure; IRF; intraretinal fluid; nAMD, neovascular age-related macular degeneration; NEI VFQ-25, National Eye Institute Visual Functioning Questionnaire-25;OCT, optical coherence tomography; SRF, subretinal fluid; TEAEs, treatment-emergent adverse events.}

_Disclaimers

_{These presentations contain data that has not yet been published in a peer-reviewed journal; the publications reporting this data are currently either in development or planned to be developed in the near future. Data presented at conferences (abstracts, oral presentations, posters) may differ from final publication in peer-reviewed journals.}

_{These presentations contain information regarding indications and/or instructions which differ from the approved use of products available in Canada.}

_{Any decisions related to the use of these materials rest with you. Any medical conclusions that you may derive from the content of these materials is based on your medical judgment.}

_{For complete product information, please refer to the respective product monograph available through Health Canada’s website:}_{https://health-products.canada.ca/dpd-bdpp/index-eng.jsp}

_{MA-AFL_8mg-CA-0144-1}