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Trial record 1 of 1 for:    PULSAR 20968
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Study to Gather Information on Safety and Use of High Dose Aflibercept Injection Into the Eye in Patients With an Age Related Eye Disorder That Causes Blurred Vision or a Blind Spot Due to Abnormal Blood Vessels That Leak Fluid Into the Light Sensitive Lining Inside the Eye (PULSAR)

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ClinicalTrials.gov Identifier: NCT04423718
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : December 28, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321) Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1011 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Up to Week 108 - Participant and Investigator masked Week 108 to Week 156 - Participant and Investigator unmasked to treatment intervals
Primary Purpose: Treatment
Official Title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Actual Study Start Date : August 11, 2020
Actual Primary Completion Date : July 18, 2022
Estimated Study Completion Date : August 12, 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Aflibercept 2q8
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
 Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection

Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Solution in Vial, 2 mg, intravitreal (IVT) injection
Experimental: Aflibercept HDq12
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
 Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection
Experimental: Aflibercept HDq16
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
 Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection


Outcome Measures
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Primary Outcome Measures :
  1. Change in best corrected visual acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: At baseline and week 48 ]

Secondary Outcome Measures :
  1. Change in BCVA measured by the ETDRS letter score [ Time Frame: At baseline and week 60 ]
  2. Proportion of participants with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in central subfield [ Time Frame: At week 16 ]
  3. Proportion of participants gaining at least 15 letters in BCVA [ Time Frame: At baseline and week 48 ]
  4. Proportion of participants achieving an ETDRS letter score of at least 69 [ Time Frame: At week 48 ]
  5. Change in choroidal neovascularization (CNV) size [ Time Frame: At baseline and week 48 ]
  6. Change in total lesion area [ Time Frame: At baseline and week 48 ]
  7. Proportion of participants with no IRF and no SRF in the center subfield [ Time Frame: At week 48 ]
  8. Change in central subfield retinal thickness (CST) [ Time Frame: At baseline and week 48 ]
  9. Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total score [ Time Frame: At baseline and week 48 ]
  10. Treatment-emergent adverse events (AEs) and serious AEs (SAEs) [ Time Frame: Up to 156 weeks ]
  11. Systemic exposure to aflibercept as assessed by plasma concentration [ Time Frame: Up to week 48 ]
  12. Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response [ Time Frame: Up to week 96 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 central subfield retinal thickness (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.
  • Other protocol-specified exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423718


Locations
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Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04423718    
Other Study ID Numbers: 20968
2019-003851-12 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: December 28, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayer:
nAMD
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents