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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05850520




Registration number
NCT05850520
Ethics application status
Date submitted
28/04/2023
Date registered
9/05/2023
Date last updated
16/05/2024

Titles & IDs
Public title
A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
Scientific title
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion
Secondary ID [1] 0 0
2022-502174-16-00
Secondary ID [2] 0 0
22153
Universal Trial Number (UTN)
Trial acronym
QUASAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema Secondary to Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
Treatment: Drugs - Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg
Treatment: Drugs - Sham
Diagnosis / Prognosis - Fluorescein

Experimental: Higher Dose Regimen 1 - Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.

Experimental: Higher Dose Regimen 2 - Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.

Active Comparator: Standard of care - Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.


Treatment: Drugs: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose
Intravitreally (IVT) injection.

Treatment: Drugs: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg
Intravitreally (IVT) injection.

Treatment: Drugs: Sham
Sham procedure will be given on visits when an active injection is not planned.

Diagnosis / Prognosis: Fluorescein
Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in BCVA measured by the ETDRS letter score at Week 36
Timepoint [1] 0 0
At Week 36
Secondary outcome [1] 0 0
Number of active injections from baseline to Week 64
Timepoint [1] 0 0
From baseline to Week 64
Secondary outcome [2] 0 0
Number of active injections from baseline to Week 36
Timepoint [2] 0 0
From baseline to Week 36
Secondary outcome [3] 0 0
Change from baseline in BCVA measured by the ETDRS letter score at Week 44
Timepoint [3] 0 0
At baseline, week 44
Secondary outcome [4] 0 0
Change from baseline in BCVA measured by the ETDRS letter score at Week 64
Timepoint [4] 0 0
At baseline, week 64
Secondary outcome [5] 0 0
Number of participants gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64
Timepoint [5] 0 0
From baseline at week 36 and week 64
Secondary outcome [6] 0 0
Number of participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64
Timepoint [6] 0 0
At week 36 and week 64
Secondary outcome [7] 0 0
Participant having no IRF and no SRF in the center subfield at Weeks 36 and 64 (yes/no)
Timepoint [7] 0 0
At week 36 and week 64
Secondary outcome [8] 0 0
Change from baseline in CST at Weeks 36 and 64
Timepoint [8] 0 0
At baseline, week 36 and week 64
Secondary outcome [9] 0 0
Change from baseline in NEI VFQ 25 total score at Weeks 36 and 64
Timepoint [9] 0 0
At baseline, week 36 and week 64
Secondary outcome [10] 0 0
Number of participant with TEAEs and SAEs through Weeks 36 and 64
Timepoint [10] 0 0
Through weeks 36 and 64
Secondary outcome [11] 0 0
Participants dosed only Q8W through Week 36 in the 8 mg Q8W group
Timepoint [11] 0 0
Through weeks 36
Secondary outcome [12] 0 0
Participants having last treatment intervals =12 or of 16 weeks at Week 64
Timepoint [12] 0 0
At week 64
Secondary outcome [13] 0 0
Participants having next intended interval =12 or of 16 weeks at Week 64
Timepoint [13] 0 0
At week 64
Secondary outcome [14] 0 0
Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64
Timepoint [14] 0 0
From baseline through weeks 36 and 64

Eligibility
Key inclusion criteria
- Adult =18 years of age (or country's legal age of adulthood if the legal age is >18
years) at the time of signing the informed consent.

- Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO,
HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the
study eye.

- Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to
20/320) at screening and baseline visits in the study eye.

Decrease in BCVA determined to be primarily the result of RVO in the study eye.

- Mean CST =300 µm on optical coherence tomography (OCT) if excluding Bruch's membrane
(e.g., Cirrus or Topcon) or =320 µm if including Bruch's membrane (e.g., Heidelberg
Spectralis), confirmed by the reading center at the screening visit and by the site at
baseline visit in the study eye.

- Capable of giving signed informed consent form (ICF) by study participant or legally
acceptable representative, which includes compliance with the requirements and
restrictions listed in the ICF and in this protocol.

- US participants will be required to have a Health Insurance Portability and
Accountability Act (HIPAA) authorization; in other countries, as applicable according
to national laws.

- Women of childbearing potential (WOCBP) or men who are sexually active with partners
of childbearing potential must agree to use highly effective contraception prior to
the initial dose/start of the first treatment, during the study, and for at least 4
months after the last administration of study intervention. Contraceptive use by men
or women should be consistent with local regulations regarding the methods of
contraception for participation in clinical studies and fulfil the conditions set on
Section 10.4.2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA
recovery or is likely to require medical or surgical intervention during the study in
the study eye.

- Presence or history of the following ocular conditions:

1. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy)
in the study eye.

2. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants
as diabetic retinopathy lesions outside the area of the vein occlusion in the
study eye and anywhere in the retina in the fellow eye.

3. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in
the study eye.

4. Vitreomacular traction, epiretinal membrane or structural damage to the macula
that is considered by the Investigator to significantly affect central vision or
preclude improvement in vision in the study eye.

5. Macular hole of stage 2 and above in the study eye.

6. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive
or cataract surgery in the study eye.

7. Corneal transplant or corneal dystrophy in the study eye.

8. Idiopathic or autoimmune uveitis in the study or in the fellow eye.

- Presence of the following ocular conditions at screening or baseline visit:

1. Significant media opacities, including cataract, that interfere with BCVA, or
imaging assessments (e.g., fundus photography [FP], OCT) in the study eye.

2. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as
a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more
than 30 days before the screening visit), in the study eye.

3. Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with
anti-glaucoma medication); or history or likely future need of glaucoma surgery
in the study eye.

4. Intraocular inflammation/infection (including trace, or above, cells in the
anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening
visit in the study or in the fellow eye.

5. Extraocular or periocular infection or inflammation (including infectious
blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the
fellow eye.

- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at
the screening visit or baseline visit.

- Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the
screening visit.

- History of cerebrovascular accident or myocardial infarction within 24 weeks (168
days) before the screening visit or between screening and baseline visits.

- Renal failure requiring dialysis, or renal transplant at screening or potentially
during the study.

- Any prior or concomitant ocular or systemic treatment (with an investigational or
approved, anti-VEGF or other agent) or surgery for RVO in the study eye.

- Previous administration of systemic anti-angiogenic medications for any condition.

- Prior treatment of the study eye with any of the following drugs (any route of
ophthalmic administration) or procedures:

1. Anti-angiogenic drugs at any time including investigational therapy (e.g., with
anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).

2. Previous use topical steroids within 4 weeks (28 days) from the screening visit,
or intraocular or periocular steroids within 16 weeks (112 days) from the
screening visit, or steroid implants at any time.

3. Previous treatment with intraocular or periocular implant, gene therapy, or cell
therapy at any time.

4. Treatment with ocriplasmin at any time.

5. Vitreoretinal surgery (including scleral buckling) at any time.

6. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days)
before the screening visit.

7. Previous treatment with retinal laser photocoagulation.

- Prior treatment of the fellow eye with any of the following:

a. Gene therapy, or cell therapy in the fellow eye at any time.

- Participation in other clinical studies requiring administration of investigational
treatments (other than vitamins and minerals) at the time of screening visit, or
within 30 days or 5 half-lives of administration of the previous study intervention,
whichever is longer.

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
15/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/05/2025
Actual
Sample size
Target
822
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Eyeclinic Albury Wodonga - Albury
Recruitment hospital [2] 0 0
Marsden Eye Surgery Center - Parramatta
Recruitment hospital [3] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [4] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [5] 0 0
Sydney Retina Clinic - Sydney
Recruitment hospital [6] 0 0
Sydney West Retina Pty Ltd - Westmead
Recruitment hospital [7] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [8] 0 0
Hobart Eye Surgeons - Hobart
Recruitment hospital [9] 0 0
Centre for Eye Research - East Melbourne
Recruitment hospital [10] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2135 - Strathfield
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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Colorado
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Kagawa
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Mie
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Shiga
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Tokyo
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Yamaguchi
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Yamanashi
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Akita
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Nagasaki
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Osaka
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Wakayama
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Yamagata
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Busan
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Gyeonggi-do
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Seoul
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Riga
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Lithuania
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Vilnius
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Bandar Puncak Alam
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Kuala Lumpur
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Portugal
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
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Regeneron Pharmaceuticals
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Ethics approval
Ethics application status

Summary
Brief summary
Researchers are looking for a better way to treat people who have macular edema secondary to
retinal vein occlusion (RVO).

In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes
blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood
to leak into the retina and thereby causes a swelling of the macula (the center of the retina
responsible for fine vision). This swelling is called macular edema.

When a vein in the retina is blocked, the levels of a protein called vascular endothelial
growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to
macular edema and may cause the vision to become blurry.

The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It
works by blocking VEGF and this can help repair vision problems related to RVO. IVT
aflibercept is already available and is prescribed by doctors as the standard of care
treatment for macula edema secondary to RVO. Standard of care is a treatment that medical
experts consider most appropriate for a disease.

Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While
repeated injections of aflibercept may prevent worsening of vision, it may place a burden on
the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT
aflibercept is being tested in studies. This higher amount could be given less often. The
amount of IVT aflibercept given is measured in milligrams, also known as mg.

The main purpose of this study is to learn how well a higher amount of the study treatment
aflibercept works in people with macular edema secondary to RVO. To answer this, researchers
will measure changes in vision called best corrected visual acuity (BCVA) in the study
participants between study start and after 36 weeks of treatment. Changes will then be
compared between those participants who received the higher amount of IVT aflibercept and
those that received standard of care.

To learn how safe the study treatment is in the participants, the researchers will count the
number of participants from study start and up to 64 weeks later that have:

- adverse events

- serious adverse events

"Adverse events" are any medical problems that the participants have during a study. Doctors
keep track of all adverse events that happen in studies, even if they do not think they might
be related to the study treatments. An adverse event is considered "serious" when it leads to
death, puts the participants' lives at risk, requires hospitalization, causes disability,
causes a baby being born with medical problems or is otherwise medically important.

Dependent on the treatment group, the participants will either receive the higher amount of
aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study
will consist of a test (screening) phase, a treatment phase and an end of study phase. Each
participant will be in the study for up to 64 weeks.

One visit to the study site is planned during the screening phase, followed by visits
approximately every 4 weeks (16 in total) during treatment and one visit at the end of the
study.

During the study, the study doctors and their team will:

- check patients' eye health using various eye examination techniques

- measure patients' eye vision (BCVA)

- take blood and urine samples

- do physical examinations

- check vital signs

- examine heart health using electrocardiogram (ECG)

- do pregnancy tests in women of childbearing age

In addition, participants will be asked to fill a questionnaire on vision-related quality of
life.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05850520
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05850520