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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05850520
Ethics application status
Date submitted
28/04/2023
Date registered
9/05/2023

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
Active, not 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
Lion 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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United States of America
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California
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Colorado
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Turkey
State/province [158] 0 0
Bilkent Çankaya
Country [159] 0 0
Turkey
State/province [159] 0 0
Kocaeli
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Leicestershire
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Surrey
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Tyne And Wear
Country [163] 0 0
United Kingdom
State/province [163] 0 0
West Midlands
Country [164] 0 0
United Kingdom
State/province [164] 0 0
West Yorkshire
Country [165] 0 0
United Kingdom
State/province [165] 0 0
York
Country [166] 0 0
United Kingdom
State/province [166] 0 0
Liverpool
Country [167] 0 0
United Kingdom
State/province [167] 0 0
London

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05850520