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Phase 2 N=44 Randomized Quadruple-blind Treatment

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

Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02914639 ↗
Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Jun 2023
Primary outcome: Primary: Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 — 23; 21; 23; 21 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
SF0166 Topical Ophthalmic Solution (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
OcuTerra Therapeutics, Inc.
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8		 23; 21; 23; 21; 23; 20 —
PRIMARY
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8		 1; 0; 22; 21; 1; 0 —
PRIMARY
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8		 23; 21; 23; 21; 23; 20 —
PRIMARY
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8		 23; 21; 23; 21; 23; 20 —
PRIMARY
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8		 23; 21; 23; 21; 23; 20 —
PRIMARY
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8		 23; 21; 23; 21; 23; 20 —
PRIMARY
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8		 12; 7; 11; 14; 11; 8 —
PRIMARY
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8		 23; 19; 0; 2; 21; 20 —
PRIMARY
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8		 16; 8; 7; 13; 15; 6 —
PRIMARY
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8		 19; 18; 4; 3; 19; 18 —
PRIMARY
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8		 23; 21; 0; 0; 0; 1 —
PRIMARY
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8		 20; 18; 3; 3; 22; 18 —
PRIMARY
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8		 1; 2; 8; 8; 8; 8 —
PRIMARY
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline		 23; 21; 0; 0; 23; 18 —
PRIMARY
Change in Intraocular Pressure From Baseline to Week 8		 0.1; 0.5; 0.3; 1.4; -1.0; 0.5 —
PRIMARY
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8		 -1.6; 3.8; -1.3; 13.8; 26.1; -8.2 —
SECONDARY
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8		 2.8; 2.8; 2.5; 1.7; 1.3; 2.4 —

Summary

The primary purpose of this study was to evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD).

Eligibility Criteria

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 p
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02914639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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