Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)

This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with Neovascular Age-related Macular Degeneration (AMD) were randomized to 1 of 2 treatment arms in a 1:1 ratio as follows: SF0166 low dose twice daily (BID) or SF0166 high dose BID.

Study subjects administered the randomly assigned treatment for 28 days. There was an additional 28-day post-treatment follow-up period. Study subjects returned for examination every 2 weeks for 8 weeks (2 months).

Inclusion criteria

• Male or female, 50 years of age or older.
• Active subfoveal choroidal neovascularization due to Age-related Macular Degeneration (AMD) in the study eye that meet the following criteria:

• Total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas
• Choroidal neovascularization (CNV) >50% of lesion area
• Intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT)
• No atrophy or fibrosis involving the center of the fovea
• Best-corrected Visual Acuity (BCVA) between 78 and 25 letters, inclusive, in the study eye at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD).
• Treatment naïve (i.e., no previous anti--vascular endothelial growth factor [VEGF] treatment in the study eye) or previously treated study eye with adequate washout defined below:

• Lucentis (ranibizumab): 30-day washout
• Avastin (bevacizumab): 30-day washout
• Eylea (aflibercept): 60-day washout
• Macugen (pegaptanib): 45-day washout
• Willing and able to return for all study visits.
• Able to adhere to the study dosing requirements.
• Understands and signs the written informed consent form.

Exclusion criteria

• Non-study eye best corrected visual acuity (BCVA) worse than 20 letters at the screening/randomization visit using Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
• Choroidal neovascularization (CNV) in the study eye secondary to other causes (e.g., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis).
• Previous macular laser photocoagulation or ocular photodynamic therapy in the study eye.
• Media opacities or abnormalities in the study eye that would preclude visualization of the retina.
• Other retinal pathologies in the study eye that would interfere with vision.
• Retinal pigment epithelial (RPE) tear in the study eye.
• Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined by optical coherence tomography (OCT) results.
• Uncontrolled glaucoma or ocular hypertension in the study eye defined as an Intraocular Pressure (IOP) >25 millimeter of mercury (mmHg) regardless of concomitant treatment with IOP lowering medications.
• Uncontrolled hypertension defined as systolic >180 mmHg or >160 mmHg on 2 consecutive measurements (during the same visit) or diastolic >100 mmHg on optimal medical regimen
• Previous pars plana vitrectomy in the study eye.
• Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment.
• Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1 month) prior to study enrollment.
• Intravitreal/periocular/topical ocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment.
• Concomitant use any topical ophthalmic medications in the study eye, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days (3 months) prior to study enrollment and expected to stay on stable dose throughout study participation. Artificial tears are allowed.
• Chronic or recurrent uveitis in the study eye.
• Ongoing ocular infection or inflammation in either eye.
• A history of cataract surgery complicated by vitreous loss in the study eye.
• Congenital eye malformations in the study eye.
• A history of penetrating ocular trauma in the study eye.
• Mentally handicapped.
• Females of childbearing potential (i.e., who are not postmenopausal for at least 1 year or surgically sterile for at least 6 weeks prior to Visit 1 - Screening/Randomization) who are lactating, or who are pregnant as determined by a positive urine pregnancy test (UPT) at Visit 1 - Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study. Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, sexual abstinence, double barrier method, or vasectomized partner.
• Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.
• Contraindication to the study medications or fluorescein dye.
• Other ocular pathologies that in the Investigator's opinion would interfere with vision in the study eye.