Age-Related Macular DegenerationPhase 1/2NCT02914639
Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration (AMD)
A Phase 1/2 study testing SF0166 Topical Ophthalmic Solution in people with Age-Related Macular Degeneration, run by OcuTerra Therapeutics, Inc. at 12 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- SF0166 Topical Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Oct 2016to 26 Jun 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Ongoing ocular infection or inflammation in either eye.
- A history of cataract surgery complicated by vitreous loss in the study eye.
- Congenital eye malformations in the study eye.
- A history of penetrating ocular trauma in the study eye.
- Mentally handicapped.
- 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.
- Participation in any other investigational device or drug clinical research study within 30 days of Visit 1 - Screening/Randomization.
- Contraindication to the study medications or fluorescein dye.
- Other ocular pathologies that in the Investigator's opinion would interfere with vision in the study eye.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
West Texas Retina Consultants
Abilene, Texas, 79606
Retina Research Center, PLLC
Austin, Texas, 78705
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Texas Retina Associates
Fort Worth, Texas, 76104
Retina Consultants of Orange County
Fullerton, California, 92861
Retina Macula Specialists of Miami, LLC
Miami, Florida, 33126
Northern California Retina Vitreous Associates Medical Group, Inc
Mountain View, California, 94040
John Kenyon Eye Institute
New Albany, Indiana, 47150
Retinal Research Institute LLC
Phoenix, Arizona, 85014
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Spokane Eye Clinical Research
Spokane, Washington, 99204
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
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)
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).
Read the detailed 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).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- SF0166 Topical Ophthalmic Solution
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF0166 Topical Ophthalmic SolutionDrug
Also called OTT166
| Study group | Role | What they receive |
|---|---|---|
| SF0166 low dose BID | Experimental | SF0166 low dose instilled in study eye BID for 28 days of treatment. Receives: Drug: SF0166 Topical Ophthalmic Solution |
| SF0166 high dose BID | Experimental | SF0166 high dose instilled in study eye BID for 28 days of treatment. Receives: Drug: SF0166 Topical Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Results are mean plus standard deviation in per protocol population.
Measured: Week 2, Week 4, Week 6, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start5 Oct 2016
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- OcuTerra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Foulks, MD, Study chair, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914639
- Sponsor's protocol ID
- SF0166-C-002
- Status last verified
- May 2023
- First submitted
- 1 Sep 2016
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02914639
- Acronym / sponsor ID
- SF0166-C-002
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- OcuTerra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 7 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SF0166 low dose BID | Experimental | Drug: SF0166 Topical Ophthalmic SolutionSF0166 low dose instilled in study eye BID for 28 days of treatment. |
| SF0166 high dose BID | Experimental | Drug: SF0166 Topical Ophthalmic SolutionSF0166 high dose instilled in study eye BID for 28 days of treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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:
- Willing and able to return for all study visits.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF0166 Topical Ophthalmic SolutionAlso: OTT166 | Drug | SF0166 high dose BID, SF0166 low dose BID |
Primary outcome
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with no red blood cell counts in the anterior chamber
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with flare in the anterior chamber graded on a scale from 0 (none) to 4 (severe)
Number of Subjects With Absence of Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of hyphema
Number of Subjects With Absence of Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of bulbar conjunctival injection
Number of Subjects With Absence of Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of erythema
Number of Subjects With Absence of Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with absence of edema
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with any lens opacity
Number of Subjects With Abnormal Findings in Optic Nerve Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the optic nerve
Number of Subjects With Abnormal Findings in Vitreous Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the vitreous
Number of Subjects With Abnormal Findings in Fundus Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the fundus
Number of Subjects With Abnormal Findings in Macula/Choroid Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the macula/choroid
Number of Subjects With Abnormal Findings in Vessels Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 8
Number and percentage of subjects with abnormal findings in the retinal vessels
Cup:Disc Ratio of Subjects Following Fundus Examination From Baseline to Week 8
Time frame: Baseline, Week 2, Week 4, Week 6 and 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
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline
Time frame: Baseline and Week 4
Number and percentage of subjects with abnormal fluorescein angiogram findings
Change in Intraocular Pressure From Baseline to Week 8
Time frame: Week 2, Week 4, Week 6 and Week 8
Mean and standard deviation of change from Baseline in intra-ocular pressure
Change in Study Eye Central Retinal Thickness (CRT) From Baseline (Day 0) to Week 8
Time frame: Week 2, Week 4, Week 6 and Week 8
Results are mean plus standard deviation
1 secondary outcome
Change in Best-corrected Visual Acuity (BCVA) From Baseline (Day 0) at Week 4 and Week 8
Time frame: Week 2, Week 4, Week 6, and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Foulks, MD study chair
Medical Monitor
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SF0166 Topical Ophthalmic Solution in people with Age-Related Macular Degeneration, run by OcuTerra Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With No Cells Observed Following Slit Lamp Examination From Baseline to Week 8 (time frame: Baseline, Week 2, Week 4, Week 6 and Week 8). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.