| Eligibility |
Inclusion Criteria:
1. Male or female = 50 years of age.
2. Willing and able to provide written informed consent prior to any study procedure.
Willing and able to comply with all protocol requirements, schedules, and procedures.
3. Treatment-naïve, active choroidal subfoveal neovascularization lesions secondary to
Age-related Macular Degeneration (AMD) evidenced by Fluorescein Angiography (FA) and
Indocyanine Green Angiography (ICGA) (including PCV) in the study eye evidenced by
subfoveal FA/ICGA leakage, or definite subfoveal fluid by spectrum domain optical
coherence tomography (SD-OCT) at screening by the Study Doctor but confirmed by the
independent image reading center.
1. Active Choroidal neovascularization (CNV) area occupies at least 50% of the total
lesion area in the study eye.
2. Total lesion area (including blood, scars, and vascularization) is =9.0 Disc
Areas (DA) in the study eye.
4. Best corrected visual acuity (BCVA) letter score of 78 to 25 inclusive, using Early
Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series number charts in
the study eye at screening and at Day 1 prior to randomization (20/32 to 20/320
Snellen equivalent). The fellow (non-study) eye should not have BCVA letter score less
than 19 letters (20/400 Snellen equivalent).
5. Women of childbearing potential with a negative serum pregnancy test at screening must
agree to use protocol-defined methods of contraception for 30 days prior to the first
dose of the study and throughout the study until 3 months after the last injection of
Eylea or SCB-420.
6. Males with female partners of childbearing potential must agree to use
protocol-defined methods of contraception and agree to refrain from donating sperm
throughout the study until 3 months after the last injection of Eylea or SCB-420.
7. Have ocular media (lens, cornea, vitreous) of adequate clarity to permit high quality
fundus imaging.
Exclusion Criteria:
Study Eye
1. Sub- or intra-retinal hemorrhage that comprises more than 50% of the entire lesion or
presence of blood with the size of 1 Disc Areas (DA) or more involving the center of
fovea.
2. Have scarring or fibrosis making up greater than 50% of total lesion in the study eye
at screening; and/or scarring, fibrosis or atrophy involving the center of the fovea
in the study eye at screening.
3. Choroidal neovascularization due to other causes, such as ocular histoplasmosis,
trauma, punctate inner choroidopathy/multifocal choroiditis, angioid streaks, history
of choroidal rupture, or pathologic myopia.
4. History of macular hole of Stage 2 and above.
5. Macular pathology other than Age-related Macular Degeneration that might compromise
central vision, i.e., vitreomacular traction or significant epiretinal membrane.
Polypoid choroidal vasculopathy identified on screening ICGA is not exclusionary.
6. Presence of retinal pigment epithelial tears or rips involving the macula.
7. History of any vitreous hemorrhage in the study eye within 8 weeks prior to the
screening visit.
8. History of retinal detachment, treatment, or surgery for retinal detachment in the
study eye.
9. Uncontrolled ocular hypertension (defined as Intraocular Pressure (IOP) =22 mmHg
despite treatment with anti-glaucoma medication) at screening.
10. Significant media opacities, including Lens Opacities Classification System (LOCS) II
Grade IV cataract in the study eye, or other significant cataract in the study eye
that in the investigator's opinion interferes with visualization of retina or
interferes with retinal imaging.
11. Aphakia or absence of the posterior capsule (unless it occurred as a result of a
yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior
posterior chamber Intraocular Lens (IOL) implantation) in the study eye.
12. History or evidence of any other clinically significant disorder, condition or disease
(e.g., co-existence of retinal vein occlusion (RVO), radiation retinopathy, diabetic
retinopathy, glaucoma under treatment) in the study eye that, in the opinion of the
investigator, would pose a risk to subject safety or interfere with the study
evaluation, procedure or complication.
13. Have active intraocular inflammation in either eye at screening or upon examination at
baseline or a history of uveitis in either eye.
14. Have active ocular or periocular infection in either eye, or a history of any ocular
or periocular infection within the 2 weeks prior to screening in either eye.
Study Eye - Ocular Treatment/Surgical History
15. Any prior ocular or systemic treatment, surgery, or investigational product for
neovascular Age-related Macular Degeneration, including anti-vascular endothelial
growth factor (anti-VEGF) therapy, except dietary supplements or vitamins.
16. Prior treatment with intravitreal (IVT) anti-VEGF therapy for any other indication.
17. Have participated as a subject in any interventional clinical trial within 1 month (30
days) prior to the baseline visit.
18. History of vitrectomy or treatment of the macula with verteporfin (photodynamic
therapy), transpupillary thermotherapy, radiation therapy, or retinal laser treatment
(e.g., focal laser photocoagulation) in the study eye.
19. History of laser therapy of the macula.
20. History of glaucoma-filtering surgery within 3 months of Day 1 in the study eye.
Anti-glaucoma laser surgeries are allowed.
21. History of corneal transplant or presence of a corneal dystrophy that interferes with
intraocular pressure measurements or imaging in the study eye.
22. Any other intraocular or periocular surgery within 3 months prior to Day 1. Lid
surgery prior to 1 month of Day 1 is allowed. Uncomplicated neodymium-doped yttrium
aluminium garnet (Nd:YAG) laser capsulotomy performed for secondary opacification of
the posterior capsule in IOL-implanted eye within 3 months prior to Day 1 is allowed.
23. History of intravitreal or periocular injections of corticosteroids within 6 months
prior to screening in the study eye or device implantation in the prior 36 months.
24. Have any use of long acting intraocular steroids, including implants, within 6 months
prior to Day 1, baseline.
Either Eye
25. History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME), or
any other vascular disease affecting the retina, other than Age-related Macular
Degeneration in either eye.
26. Active intraocular inflammation or active or suspected ocular or periocular infection,
within 2 weeks before Day 1.
27. Active scleritis or episcleritis or presence of scleromalacia.
Other
28. Uncontrolled hypertension defined as systolic blood pressure >180 mmHg or diastolic
blood pressure >100 mmHg under appropriate antihypertensive treatment.
29. Thrombotic event(s) (e.g., stroke, transient ischemic attacks, pulmonary embolism,
deep vein thrombosis, or myocardial infarction) within 6 months of screening.
30. History or evidence of cardiac conditions, including congestive cardiac failure
leading to marked limitation on physical activity, or inability to perform any
physical activity without discomfort, ventricular arrhythmia requiring ongoing
treatment, and atrial fibrillation.
31. Prior treatment with systemic anti-vascular endothelial growth factor (anti-VEGF)
therapy.
32. Any concomitant or prior treatment with ethambutol (2 weeks prior to Day 1);
deferoxamine and topiramate (4 weeks prior to Day 1); tamoxifen, hydroxychloroquine,
chloroquine, or vigabatrin (8 weeks prior to Day 1), and amiodarone (12 weeks prior to
Day 1).
33. Any investigational product administered for the treatment of neovascular Age-related
Macular Degeneration prior to screening; and any investigational product (except
dietary supplements, minerals or vitamins) for the treatment of ocular diseases or
systemic diseases 30 days or 5 half-lives (whichever is longer), prior to screening,
(see Table 5-1 for the list of prohibited medications).
34. Any prior or ongoing systemic medical condition (including but not limited to
infectious, inflammatory, psychiatric, neurological, renal, hepatic, respiratory
conditions or malignancies) or clinically significant screening laboratory value that
in the opinion of the investigator may present a safety risk, interfere with study
compliance and follow-up, or confound data interpretation throughout the study period.
35. Hypersensitivity to aflibercept, any of the excipients in SCB-420 or Eylea, or
medications used during study procedures, (fluorescein, mydriatic eye drops, etc.), or
any contraindication to study procedures or intravitreal injections, according to
investigator judgment.
36. Any known allergy to povidone iodine or known serious allergy to the fluorescein
sodium for injection in angiography.
|
