Overview

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

Status:
Completed
Trial end date:
2017-06-26
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SciFluor Life Sciences, Inc.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
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.