Diabetic Macular EdemaPhase 1/2NCT02914613

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

A Phase 1/2 study testing SF0166 Topical Ophthalmic Solution in people with Diabetic Macular Edema, run by OcuTerra Therapeutics, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
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: 6 sitesUnited States
Study dates: 24 Aug 2016to 16 May 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

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.

Show all 25Show fewer

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.
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 the subject's vision in the study eye.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Retina Consultants of Houston
Houston, Texas, 77030
United Medical Research Institute
Inglewood, California, 90301
Martel Eye Medical Group
Rancho Cordova, California, 95670
Center for Retina and Macular Disease
Winter Haven, Florida, 33880

Other trials in United States

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 Diabetic Macular Edema (DME)

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).

Read the detailed description

This was a prospective, randomized, double-masked, multicenter, Phase I/II clinical study in which 44 eligible subjects with active Diabetic Macular Edema (DME) 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: Diabetic Macular Edema
Being tested: SF0166 Topical Ophthalmic Solution

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 Ophthalmic Solution

Study groups in NCT02914613
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
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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2,4,6 and 8 weeks
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Measured: 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
Measured: 2, 4, 6 and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 201616 May 2017

First posted26 Sep 2016 (estimated)
Study start24 Aug 2016
Primary completion16 May 2017
Study completion16 May 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 Diabetic Macular EdemaStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914613
Sponsor's protocol ID: SF0166-C-001
Status last verified: May 2023
First submitted: 1 Sep 2016
Last updated: 11 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 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 Diabetic Macular Edema (DME)
ClinicalTrials.gov ID: NCT02914613
Acronym / sponsor ID: SF0166-C-001
Conditions: Diabetic Macular Edema
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: 24 Aug 2016 (actual)
Primary completion: 16 May 2017 (actual)
Study completion: 16 May 2017 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 11 May 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 Diabetic Macular Edema (DME).

Detailed description

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: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
Willing and able to return for all study visits.

Key exclusion criteria (25 listed)

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.

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 Ophthalmic Solution	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, 2, 4, 6, and 8 weeks
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
Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2, 4, 6, and 8 weeks
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 Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2, 4, 6 and 8 weeks
Number and percentage of subjects with hyphema
Number of Subjects With Bulbar Conjunctival Injection Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2,4,6 and 8 weeks
Number and percentage of subjects with bulbar conjunctival injection
Number of Subjects With Erythema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2, 4, 6 and 8 weeks
Number and percentage of subjects with erythema
Number of Subjects With Edema Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2,4, 6 and 8 weeks
Number and percentage of subjects with edema
Number of Subjects With Any Lens Opacity Observed Following Slit Lamp Examination From Baseline to Week 8
Time frame: Baseline, 2,4,6 and 8 weeks
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, 2,4,6 and 8 weeks
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, 2,4,6 and 8 weeks
Number and percentage of subjects (both eyes) 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, 2,4,6 and 8 weeks
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, 2,4,6 and 8 weeks
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, 2,4,6 and 8 weeks
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, 2,4,6 and 8 weeks
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
Number of Subjects With Abnormal Findings Following A Fluorescein Angiogram at Week 4 Compared to Baseline (Day 0)
Time frame: Baseline and 4 weeks
Number and percentage of subjects with abnormal fluorescein angiogram findings
Change in Intraocular Pressure From Baseline to Week 8
Time frame: 2,4,6 and 8 weeks
Mean and standard deviation of change from Baseline in intra-ocular pressure
Change in Central Retinal Thickness (CRT) for Study Eye From Baseline (Day 0) to Week 8
Time frame: 2,4,6 and 8 weeks

1 secondary outcome

Change in Best-corrected Visual Acuity (BCVA) for Study Eye From Baseline (Day 0) at Week 4 and Week 8
Time frame: 2, 4, 6 and 8 weeks

Results and safety

Results posted to the registry on 11 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SF0166 Low Dose 2.5% BID	22	20
SF0166 High Dose 5.0% BID	22	20

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

Time frame: Baseline, 2, 4, 6, and 8 weeks. Count of participants. Unit: Participants

Measure	SF0166 Low Dose 2.5% BID n = 22	SF0166 High Dose 5.0% BID n = 22
Baseline (Study Eye) - No cells seen	22	22
Baseline (Fellow Eye) - No cells seen	22	22
Week 2 (Study Eye) - No cells seen	21	21
Week 2 (Fellow Eye) - No cells seen	21	21
Week 4 (Study Eye) - No cells seen	20	19
Week 4 (Fellow Eye) - No cells seen	20	19
Week 6 (Study Eye) - No cells seen	19	20
Week 6 (Fellow Eye) - No cells seen	19	20

Population analysed: The analysis population at Baseline includes all randomized participants, 22 in each group. Before Week 2, there were two discontinuations, one in each group. Before Week 4 there was one discontinuation in the high dose 5.0% group. One participant in each dose group missed the Week 4 visit. Prior to Week 6 there was one discontinuation in the low dose 2.5% group. One low dose 2.5% group participant missed the Week 6 visit. At Week 8, all the non-discontinued were assessed, 20 in each dose group.

Primary outcome: Number of Subjects With Flare Observed Following Slit Lamp Examination From Baseline to Week 8

Time frame: Baseline, 2, 4, 6, and 8 weeks. Count of participants. Unit: Participants

Measure	SF0166 Low Dose 2.5% BID n = 22	SF0166 High Dose 5.0% BID n = 22
Baseline (Study Eye)	0	0
Baseline (Fellow Eye)	0	0
Week 2 (Study Eye)	0	0
Week 2 (Fellow Eye)	0	0
Week 4 (Study Eye)	0	0
Week 4 (Fellow Eye)	0	0
Week 6 (Study Eye)	0	0
Week 6 (Fellow Eye)	0	0

Primary outcome: Number of Subjects With Hyphema Observed Following Slit Lamp Examination From Baseline to Week 8

Time frame: Baseline, 2, 4, 6 and 8 weeks. Count of participants. Unit: Participants

Measure	SF0166 Low Dose 2.5% BID n = 22	SF0166 High Dose 5.0% BID n = 22
Baseline (Study Eye): Mild	0	0
Baseline (Study Eye): Absent	22	22
Baseline (Fellow Eye): Mild	0	0
Baseline (Fellow Eye): Absent	22	22
Week 2 (Study Eye): Mild	0	0
Week 2 (Study Eye): Absent	21	21
Week 2 (Fellow Eye): Mild	0	0
Week 2 (Fellow Eye): Absent	21	21

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

Time frame: Baseline, 2,4,6 and 8 weeks. Count of participants. Unit: Participants

Measure	SF0166 Low Dose 2.5% BID n = 22	SF0166 High Dose 5.0% BID n = 22
Baseline (Study Eye): Mild	0	0
Baseline (Study Eye): Absent	22	22
Baseline (Fellow Eye): Mild	0	1
Baseline (Fellow Eye): Absent	22	21
Week 2 (Study Eye): Mild	0	0
Week 2 (Study Eye): Absent	21	21
Week 2 (Fellow Eye): Mild	0	0
Week 2 (Fellow Eye): Absent	21	21

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SF0166 Low Dose 2.5% BID	5 of 22 (22.7%)	10 of 22 (45.5%)	0 of 22
SF0166 High Dose 5.0% BID	1 of 22 (4.5%)	4 of 22 (18.2%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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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

6 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 Diabetic Macular Edema, run by OcuTerra Therapeutics, Inc. at 6 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 11 inclusion and 25 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 11 May 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, 2, 4, 6, and 8 weeks). 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?

On the ClinicalTrials.gov record for NCT02914613.

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 11 May 2023.