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

NCT02914613 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SF0166-C-001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 6

Brief Summary

The primary purpose of this study was to evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Diabetic Macular Edema (DME).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (16)

• Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8

  Percentage of subjects with red blood cell counts in the anterior chamber in the ranges from 0 to \> 30 with the higher number being worse

  Baseline, 2, 4, 6, and 8 weeks

• 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).

  Baseline, 2, 4, 6, and 8 weeks

• Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8

  Number and percentage of subjects with hyphema

  Baseline, 2, 4, 6 and 8 weeks

• Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8

  Number and percentage of subjects with bulbar conjunctival injection

  Baseline, 2,4,6 and 8 weeks

• Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8

  Number and percentage of subjects with erythema

  Baseline, 2, 4, 6 and 8 weeks

• Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8

  Number and percentage of subjects with edema

  Baseline, 2,4, 6 and 8 weeks

• Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8

  Number and percentage of subjects with any lens opacity

  Baseline, 2,4,6 and 8 weeks

• 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

  Baseline, 2,4,6 and 8 weeks

• Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8

  Number and percentage of subjects (both eyes) with abnormal findings in the vitreous

  Baseline, 2,4,6 and 8 weeks

• 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

  Baseline, 2,4,6 and 8 weeks

• 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

  Baseline, 2,4,6 and 8 weeks

• 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

  Baseline, 2,4,6 and 8 weeks

• 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 0.6 with the higher number being worse

  Baseline, 2,4,6 and 8 weeks

• Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)

  Number and percentage of subjects with abnormal fluorescein angiogram findings

  Baseline and 4 weeks

• Change in Intraocular Pressure From Baseline to Week 8

  Mean and standard deviation of change from Baseline in intra-ocular pressure

  2,4,6 and 8 weeks

• Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8

  2,4,6 and 8 weeks

Secondary Outcomes (1)

• Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8

  2, 4, 6 and 8 weeks

Study Arms (2)

SF0166 low dose BID

EXPERIMENTAL

SF0166 low dose instilled in study eye BID for 28 days of treatment.

Drug: SF0166 Topical Ophthalmic Solution

SF0166 high dose BID

EXPERIMENTAL

SF0166 high dose instilled in study eye BID for 28 days of treatment.

Drug: SF0166 Topical Ophthalmic Solution

Interventions

SF0166 Topical Ophthalmic Solution DRUG

Also known as: OTT166 Ophthalmic Solution

SF0166 high dose BID; SF0166 low dose BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OcuTerra Therapeutics, Inc.: lead

Study Sites (6)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Martel Eye Medical Group

Rancho Cordova, California, 95670, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: OcuTerra Therapeutics, Inc.

info@ocuterratx.com

(617) 701-7382

Study Officials

• Gary Foulks, MD

  Medical Monitor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 26, 2016
• Study Start: August 24, 2016
• Primary Completion: May 16, 2017
• Study Completion: May 16, 2017
• Last Updated: May 11, 2023
• Results First Posted: May 11, 2023

Record last verified: 2023-05

Locations

US (6)