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

Age-Related Macular Degeneration Clinical Trial

Official title:

A Phase I/II Randomized, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of SF0166 Topical Ophthalmic Solution in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914639
• Other study ID #: SF0166-C-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 5, 2016
• Est. completion date: June 26, 2017

Study information

• Verified date: May 2023
• Source: OcuTerra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, 50 years of age or older.

2. 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

3. 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).

4. 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:

1. Lucentis (ranibizumab): 30-day washout

2. Avastin (bevacizumab): 30-day washout

3. Eylea (aflibercept): 60-day washout

4. Macugen (pegaptanib): 45-day washout

5. Willing and able to return for all study visits.

6. Able to adhere to the study dosing requirements.

7. Understands and signs the written informed consent form.

Exclusion Criteria:

1. 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.

2. 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).

3. Previous macular laser photocoagulation or ocular photodynamic therapy in the study eye.

4. Media opacities or abnormalities in the study eye that would preclude visualization of the retina.

5. Other retinal pathologies in the study eye that would interfere with vision.

6. Retinal pigment epithelial (RPE) tear in the study eye.

7. Significant epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined by optical coherence tomography (OCT) results.

8. 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.

9. 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

10. Previous pars plana vitrectomy in the study eye.

11. Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment.

12. Yttrium aluminium garnet (YAG) laser treatment in the study eye within 30 days (1 month) prior to study enrollment.

13. Intravitreal/periocular/topical ocular steroids of any type in the study eye within 90 days (3 months) prior to study enrollment.

14. 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.

15. Chronic or recurrent uveitis in the study eye.

16. Ongoing ocular infection or inflammation in either eye.

17. A history of cataract surgery complicated by vitreous loss in the study eye.

18. Congenital eye malformations in the study eye.

19. A history of penetrating ocular trauma in the study eye.

20. Mentally handicapped.

21. 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.

22. Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.

23. Contraindication to the study medications or fluorescein dye.

24. Other ocular pathologies that in the Investigator's opinion would interfere with vision in the study eye.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• SF0166 Topical Ophthalmic Solution

Locations

Country	Name	City	State
United States	West Texas Retina Consultants	Abilene	Texas
United States	Retina Research Center, PLLC	Austin	Texas
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Texas Retina Associates	Fort Worth	Texas
United States	Retina Consultants of Orange County	Fullerton	California
United States	Retina Macula Specialists of Miami, LLC	Miami	Florida
United States	Northern California Retina Vitreous Associates Medical Group, Inc	Mountain View	California
United States	John Kenyon Eye Institute	New Albany	Indiana
United States	Retinal Research Institute LLC	Phoenix	Arizona
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
OcuTerra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Week 2, Week 4, Week 6, and Week 8