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

NCT02914639 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SF0166-C-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (16)

• 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

  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)

  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

  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

  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

  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

  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

  Number and percentage of subjects with any lens opacity

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Week 2, Week 4, Week 6 and Week 8

Secondary Outcomes (1)

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

  Week 2, Week 4, Week 6, and Week 8

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

SF0166 high dose BID; SF0166 low dose BID

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OcuTerra Therapeutics, Inc.: lead

Study Sites (12)

Retinal Research Institute LLC

Phoenix, Arizona, 85014, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92861, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc

Mountain View, California, 94040, United States

Location

Retina Macula Specialists of Miami, LLC

Miami, Florida, 33126, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

John Kenyon Eye Institute

New Albany, Indiana, 47150, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

West Texas Retina Consultants

Abilene, Texas, 79606, United States

Location

Retina Research Center, PLLC

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

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: October 5, 2016
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: June 7, 2023
• Results First Posted: June 7, 2023

Record last verified: 2023-05

Locations

US (12)