Safety and Exploratory Efficacy Study of SF0166 for the Treatment of Diabetic Macular Edema (DME)

This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with active Diabetic Macular Edema (DME) 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, 18 years of age or older.
• Retinal thickening secondary to type 1 or type 2 diabetes mellitus with Diabetic Macular Edema (DME) defined as central subfield thickness ≥325 microns (µm) on spectral domain OCT in the study eye.
• 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 Diabetic Macular Edema (DME).
• 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

• Active proliferative diabetic retinopathy (PDR) in the study eye, such as neovascularization of the optic disc (NVD), neovascularization elsewhere (NVE), vitreous hemorrhage, or neovascular glaucoma.
• 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.
• Screening glycated hemoglobin (HbA1c) blood test >12.0%.
• Previous panretinal photocoagulation (PRP) in the study eye within 4 months of study enrollment, or the need for PRP during the study based on the Investigator's opinion.
• Previous focal laser photocoagulation in the study eye, within the foveal avascular zone.
• Intravitreal/periocular/topical ocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment.
• Placement of Iluvien or Retisert (fluocinolone acetonide intravitreal implant) in the study eye within 36 months (3 years) prior to study enrollment.
• Use of Ozurdex (dexamethasone intravitreal implant) in the study eye within 180 days (6 months) prior to study enrollment.
• Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined by the optical coherence tomography (OCT) results.
• 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.
• Concomitant use of 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.
• High myopia in the study eye, with a spherical equivalent of >8.00 Diopters (D) at screening.
• 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 the subject's vision in the study eye.