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

JRCT ID: jRCT2080225260

Registered date:02/07/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Neovascular Age-Related Macular Degeneration
• Date of first enrollment: 25/07/2020
• Target sample size: 960
• Countries of recruitment: Japan,Asia except Japan,North America,South America,Europe,Oceania
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : High Dose Aflibercept
INN of investigational material : High Dose Aflibercept
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : High Dose Aflibercept administered at a treatment interval A or B after a loading phase.
Solution in Vial, intravitreal (IVT) injection

control material(s)
Generic name etc : Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
INN of investigational material : Aflibercept
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : Aflibercept 2 mg administered every 8 weeks after a loading phase.
Solution in Vial, 2 mg, intravitreal (IVT) injection

Outcome(s)

Primary Outcome

efficacy
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Bayer Yakuhin, Ltd.
• Secondary Sponsor: Regeneron Pharmaceuticals
• Secondary ID(s): NCT04423718,JapicCTI-205356