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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04423718




Registration number
NCT04423718
Ethics application status
Date submitted
8/06/2020
Date registered
9/06/2020
Date last updated
30/11/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2019-003851-12
Secondary ID [2] 0 0
20968
Universal Trial Number (UTN)
Trial acronym
PULSAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Treatment: Drugs - Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)

Active Comparator: Aflibercept 2q8 - Aflibercept 2 mg administered every 8 weeks after a loading phase.

Experimental: Aflibercept high dose (HD)q Interval A - Aflibercept high dose administered at a treatment interval A after a loading phase.

Experimental: Aflibercept (HD)q Interval B - Aflibercept high dose administered at a treatment interval B after a loading phase.


Treatment: Drugs: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)
Solution in Vial, intravitreal (IVT) injection

Treatment: Drugs: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Solution in Vial, 2 mg, intravitreal (IVT) injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in best corrected visual acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Timepoint [1] 0 0
At baseline and week 48
Secondary outcome [1] 0 0
Change in BCVA measured by the ETDRS letter score
Timepoint [1] 0 0
At baseline and week 60
Secondary outcome [2] 0 0
Proportion of participants with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in central subfield
Timepoint [2] 0 0
At week 16
Secondary outcome [3] 0 0
Proportion of participants gaining at least 15 letters in BCVA
Timepoint [3] 0 0
At baseline and week 48
Secondary outcome [4] 0 0
Proportion of participants achieving an ETDRS letter score of at least 69
Timepoint [4] 0 0
At week 48
Secondary outcome [5] 0 0
Change in choroidal neovascularization (CNV) size
Timepoint [5] 0 0
At baseline and week 48
Secondary outcome [6] 0 0
Change in total lesion area
Timepoint [6] 0 0
At baseline and week 48
Secondary outcome [7] 0 0
Proportion of participants with no IRF and no SRF in the center subfield
Timepoint [7] 0 0
At week 48
Secondary outcome [8] 0 0
Change in central subfield retinal thickness (CST)
Timepoint [8] 0 0
At baseline and week 48
Secondary outcome [9] 0 0
Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total score
Timepoint [9] 0 0
At baseline and week 48
Secondary outcome [10] 0 0
Treatment-emergent adverse events (AEs) and serious AEs (SAEs)
Timepoint [10] 0 0
Up to 96 weeks
Secondary outcome [11] 0 0
Systemic exposure to aflibercept as assessed by plasma concentration
Timepoint [11] 0 0
Up to week 48
Secondary outcome [12] 0 0
Assessment of immunogenicity to aflibercept by measuring the incidence of treatment-emergent anti-drug antibodies (ADA) response
Timepoint [12] 0 0
Up to week 96

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Sydney Retina Clinic - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [5] 0 0
Marsden Eye Surgery Center - Parramatta
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
2150 - Parramatta
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04423718
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04423718