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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Retinal Research Institute LLC
Phoenix, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc
Mountain View, California, United States
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe)
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of hyphema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of bulbar conjunctival injection
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of erythema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Number and percentage of subjects with absence of edema
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
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Retina Macula Specialists of Miami, LLC
Miami, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
John Kenyon Eye Institute
New Albany, Indiana, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
West Texas Retina Consultants
Abilene, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
...and 2 more locations
Number and percentage of subjects with any lens opacity
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the optic nerve
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the vitreous
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the fundus
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the macula/choroid
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with abnormal findings in the retinal vessels
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Number and percentage of subjects with specified Cup:Disc ratio in the range from 0.1 to 0.9 with the higher number being worse
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Number and percentage of subjects with abnormal fluorescein angiogram findings
Time frame: Baseline and Week 4
Change in Intraocular Pressure From Baseline to Week 8
Mean and standard deviation of change from Baseline in intra-ocular pressure
Time frame: Week 2, Week 4, Week 6 and Week 8
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Results are mean plus standard deviation
Time frame: Week 2, Week 4, Week 6 and Week 8
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Results are mean plus standard deviation in per protocol population.
Time frame: Week 2, Week 4, Week 6, and Week 8