Diabetic RetinopathyPhase 2NCT05409235
Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
A Phase 2 study testing OTT166 in people with Diabetic Retinopathy, run by OcuTerra Therapeutics, Inc. at 68 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- OTT166
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 68 sitesin 2 countries
- Study dates
- 29 Jul 2022to 29 Dec 2023
- Phase
- Phase 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
- Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR [DRSS levels 47 or 53], or mild PDR [DRSS level 61] NVE < 0.5 DA in 1 + quadrants], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator
- BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
- Normal foveal contour
- Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)
- Willing and able to return for all study visits and comply with study-related procedures
- Able to adhere to the study dosing requirements
- Understands and signs the written Informed Consent Form
Who cannot join
- CST of > 325 μm
- Fluid in the central subfield is allowed so long as CST is ≤325 μm and there is a normal foveal contour as determined by the Central Reading Center
- Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)
- Eyes with DRSS score 61 with fibrous proliferations at disc or fibrous proliferations elsewhere a. DRSS score 61B with NVE only is allowed. Any sign of fibrosis proliferation is exclusionary
- Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
- Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed
Show all 34Show fewer
- Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
- Uncontrolled glaucoma or ocular hypertension in the study eye defined as an IOP > 25 mmHg regardless of concomitant treatment with IOP-lowering medications
- Hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic > 100 mmHg
- Screening HbA1c blood test > 12.0%
- Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications
- Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months
- Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined to be significant by the Investigator
- Previous pars plana vitrectomy in the study eye
- Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment
- YAG laser treatment in the study eye within 90 days 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 prior to study enrollment and expected to stay on stable dose throughout study participation. Topical eyedrops are allowed but not within ±10 minutes of study drop application
- Contact lens use from time of screening throughout the study
- Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome
- Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision (peripheral processes are not exclusionary)
- 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
- Cognitive impairment that, in the opinion of the investigator, could compromise compliance with the requirements of the study
- Females of childbearing potential (ie, 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 serum pregnancy test at Visit 1 -Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study a. Women who are breastfeeding or who have a positive serum hCG/urine pregnancy test at the screening or BL Visit
- Females and males of childbearing potential unwilling or unable to utilize the following acceptable methods of birth control: tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, diaphragm or cervical cap with spermicide, or vasectomized partner for females; condoms with spermicidal agent and vasectomy for males; or sexual abstinence for males and females
- Participation in any other investigational device or drug clinical research study within 12 weeks of Visit 1 - Screening/Randomization and during the duration of enrollment
- Contraindication to the study medications or fluorescein dye
- Other ocular pathologies that, in the investigator's opinion, would interfere with the participant's vision in the study eye
- Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and OCT images in the study eye
- Concomitant use of Semaglutide (Wegovy®, Ozempic®, Rybelsus®), Thiazolidinediones (Actos®, Avandia®), Liraglutides (Victoza®, Saxenda®), Dulaglutide (Trulicity®), or Tirzepatide (Mounjaro®) within 12 months prior to Visit 1 (allowed if a stable dose has been established for at least 1 year of use) a. Plans to start concomitant use of Semaglutide or Thiazolidinediones during the study duration is exclusionary
Trial locations and contacts
68 sites in 2 countries.
68 sites in 2 countries
United States67 sites
Clinical Site 112
‘Aiea, Hawaii, 96701
Clinical Site 118
Albuquerque, New Mexico, 87109
Clinical Site 161
Austin, Texas, 78705
Clinical Site 163
Baltimore, Maryland, 21237
Clinical Site 145
Baltimore, Maryland, 21287
Clinical Site 143
Beachwood, Ohio, 44122
Clinical Site 130
Beaufort, South Carolina, 29902
Clinical Site 102
Bellaire, Texas, 77401
Clinical Site 108
Bellaire, Texas, 77401
Clinical Site 111
Beverly Hills, California, 90211
Clinical Site 105
Bloomfield, New Jersey, 07003
Clinical Site 151
Boston, Massachusetts, 02111
Clinical Site 104
Boston, Massachusetts, 02114
Clinical Site 147
Burleson, Texas, 76028
Clinical Site 136
Cherry Hill, New Jersey, 08034
Clinical Site 120
Cleveland, Ohio, 44122
Clinical Site 157
Coral Springs, Florida, 33067
Clinical Site 141
Detroit, Michigan, 48201
Clinical Site 152
Dublin, Ohio, 43016
Clinical Site 122
Edmond, Oklahoma, 73013
Clinical Site 113
Encino, California, 91436
Clinical Site 106
Fort Lauderdale, Florida, 33309
Clinical Site 132
Fort Worth, Texas, 76104
Clinical Site 138
Fresno, California, 93720
Clinical Site 168
Germantown, Tennessee, 38138
Clinical Site 103
Hagerstown, Maryland, 21740
Clinical Site 156
Houston, Texas, 77025
Clinical Site 129
Huntington Beach, California, 92647
Clinical Site 154
Indianapolis, Indiana, 46290-1166
Clinical Site 131
Jacksonville, Florida, 32216
Clinical Site 115
Kingston, Pennsylvania, 18704
Clinical Site 164
Knoxville, Tennessee, 37909-2686
Clinical Site 139
Lenexa, Kansas, 66215
Clinical Site 109
Liverpool, New York, 13088
Clinical Site 166
Louisville, Kentucky, 40206
Clinical Site 159
Lynchburg, Virginia, 24502
Clinical Site 126
McAllen, Texas, 78503
Clinical Site 169
Memphis, Tennessee, 38119
Clinical Site 167
Metairie, Louisiana, 70006
Clinical Site 110
Miami, Florida, 33143
Clinical Site 119
Nashville, Tennessee, 37203
Clinical Site 146
Oak Forest, Illinois, 60452
Clinical Site 121
Pasadena, California, 91105
Clinical Site 127
Pasadena, California, 91107
Clinical Site 123
Peoria, Arizona, 85381
Clinical Site 150
Phoenix, Arizona, 85021
Clinical Site 135
Portland, Oregon, 97239
Clinical Site 165
Raleigh, North Carolina, 27587
Clinical Site 142
Rancho Cordova, California, 95670
Clinical Site 133
Rapid City, South Dakota, 57701
Clinical Site 101
Reno, Nevada, 89502
Clinical Site 116
Riverside, California, 92505
Clinical Site 162
Rochester, New York, 14618
Clinical Site 125
Sacramento, California, 95841
Clinical Site 140
San Antonio, Texas, 78240-1375
Clinical Site 137
San Antonio, Texas, 78240
Clinical Site 149
Seattle, Washington, 98125
Clinical Site 155
Southaven, Mississippi, 38671
Clinical Site 148
Spokane, Washington, 98204
Clinical Site 128
Springfield, Illinois, 62704
Clinical Site 158
Springfield, Oregon, 97477
Clinical Site 153
St. Petersburg, Florida, 33711-1141
Clinical Site 114
Teaneck, New Jersey, 07666
Clinical Site 144
Texas City, Texas, 78240
CinCor Site 171
Torrance, California, 90505
Clinical Site 160
Walnut Creek, California, 94598-5910
Clinical Site 117
Winter Haven, Florida, 33880
About this study
Official title: OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
Read the detailed description
This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) will be randomized 2:2:1:1 into the following groups: OTT166 5% twice daily (BID), OTT166 5% four times daily (QID), vehicle control BID, vehicle control QID. Randomization will be stratified by baseline Diabetic Retinopathy Severity Scale (DRSS) score (47 or 53 or 61B). Participants with PDR (DRSS score 61B) will be capped at 20% of all randomized participants. Each group will self-administer one 50-μl eye drop of study solution (frequency as assigned) for 24 weeks.
- Conditions
- Diabetic Retinopathy
- Being tested
- OTT166, Vehicle control
- Keywords
- Diabetic Retinopathy, Ophthalmic solution, Non-proliferative diabetic retinopathy, Proliferative diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTT166Drug
Also called nesvategrast
Participants will receive OTT166 ophthalmic solution
Vehicle controlDrug
Participants will receive vehicle control
| Study group | Role | What they receive |
|---|---|---|
| OTT166 Cohort 1 | Experimental | Participants will receive OTT166 5% twice a day (BID) for 24 weeks Receives: Drug: OTT166 |
| OTT166 Cohort 2 | Experimental | Participants will receive OTT166 5% four times a day (QID) for 24 weeks Receives: Drug: OTT166 |
| Vehicle control Cohort 1 | Placebo comparator | Participants will receive vehicle control BID for 24 weeks Receives: Drug: Vehicle control |
| Vehicle control Cohort 2 | Placebo comparator | Participants will receive vehicle control QID for 24 weeks Receives: Drug: Vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Secondary outcomes (17)
Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)
To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR, DRSS of 65 and above. The higher the DRSS, the greater the risk of vision loss and thus the standard of care is to treat affected patients aggressively. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Proportion of Participants Who Developed ASNV
To determine if topical OTT166 prevented or delayed the occurrence of anterior segment neovascularization (ASNV). Measure is the percentage of patients that developed ASNV at 24 weeks. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)
To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR (wtmPDR). The determination was made using Kaplan-Meier methodology. The estimated percentage that progressed to wtmPDR by Week 24 is reported. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Proportion of Participants Who Developed CI-DME
To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
The Development of CI-DME
To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol. The percentages of participants that developed CI-DME at Week 24 are reported.
Measured: At week 24
Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC)
To determine if topical OTT166 prevented or delayed the occurrence of a VTC. VTC is defined as the composite outcome of PDR and/or ASNV and/or CI-DME.
Measured: At Week 24
Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME
To determine if topical OTT166 prevented or delayed the occurrence of PDR worse than mild (DRSS 65 and above) or CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST> 325 μm. Participants who experienced one or more events (worse than mild PDR and/or CI-DME), the earliest event date was selected. Participants who did not experience either event were censored at the earliest of the last available assessment. Median time to event is reported if calculable.
Measured: From Baseline (Day 1) up to Week 24
Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline
To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166. Change in DRSS steps is defined as DR worsening or improving by 1, 2, or ≥ 3 steps along with no change. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR
To determine the effect of OTT166 on DRSS in participants with mild PDR (DRSS 61B) treated with topical OTT166. Regression of disease was defined as decrease in DRSS to 53 or lower. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: At week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. A higher score represents better visual function.
Measured: From Baseline (Day 1) up to Week 24
Proportion of Participants With Lines Gained/Lost of BCVA
To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. Proportion of participants who gained/lost lines of BCVA (± 5, 10, and 15 ETDRS letters) were assessed. The reported data include the use of imputation according to the primary estimand as described in the protocol. 5 ETDRS letters = 1 line.
Measured: From Baseline (Day 1) up to Week 24
Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24
To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by ETDRS letters score. A higher score represents better functioning. AUC from baseline to 24 weeks is calculated by the linear trapezoidal method.
Measured: From Baseline (Day 1) up to Week 24
Change From Baseline in Central Subfield Thickness (CST)
To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by optical coherence tomography (OCT).
Measured: From Baseline (Day 1) up to Week 24
Area Under The Curve (AUC) for Change From Baseline in CST
To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by OCT.
Measured: From Baseline (Day 1) up to Week 24
Proportion of Participants Who Met the Objective Rescue Criteria
To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR.
Measured: From Baseline (Day 1) up to Week 24
Proportion That Met Objective Rescue Therapy Criteria by Week 24
To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR. The reported data include the use of imputation according to the primary estimand as described in the protocol.
Measured: From Baseline (Day 1) up to Week 24
Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered
To determine the impact of treatment with OTT166 on the time to receiving rescue therapy. Analysis was performed using the Kaplan-Meier methodology. The reported data include the use of imputation according to the primary estimand as described in the protocol. The data reported are the estimated percentages of participants at Week 24 that had had rescue therapy administered.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start29 Jul 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
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 RetinopathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- OcuTerra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Carl Regillo, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409235
- Sponsor's protocol ID
- OTT166-201
- Status last verified
- Jul 2024
- First submitted
- 3 Jun 2022
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
- ClinicalTrials.gov ID
- NCT05409235
- Acronym / sponsor ID
- OTT166-201
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Ophthalmic solution, Non-proliferative diabetic retinopathy, Proliferative diabetic retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- OcuTerra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
Detailed description
This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) will be randomized 2:2:1:1 into the following groups: OTT166 5% twice daily (BID), OTT166 5% four times daily (QID), vehicle control BID, vehicle control QID. Randomization will be stratified by baseline Diabetic Retinopathy Severity Scale (DRSS) score (47 or 53 or 61B). Participants with PDR (DRSS score 61B) will be capped at 20% of all randomized participants. Each group will self-administer one 50-μl eye drop of study solution (frequency as assigned) for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OTT166 Cohort 1 | Experimental | Drug: OTT166Participants will receive OTT166 5% twice a day (BID) for 24 weeks |
| OTT166 Cohort 2 | Experimental | Drug: OTT166Participants will receive OTT166 5% four times a day (QID) for 24 weeks |
| Vehicle control Cohort 1 | Placebo comparator | Drug: Vehicle controlParticipants will receive vehicle control BID for 24 weeks |
| Vehicle control Cohort 2 | Placebo comparator | Drug: Vehicle controlParticipants will receive vehicle control QID for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR [DRSS levels 47 or 53], or mild PDR [DRSS level 61] NVE < 0.5 DA in 1 + quadrants], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator
- BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
- Normal foveal contour
- Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)
- Willing and able to return for all study visits and comply with study-related procedures
Key exclusion criteria (34 listed)
- CST of > 325 μm
- Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)
- Eyes with DRSS score 61 with fibrous proliferations at disc or fibrous proliferations elsewhere a. DRSS score 61B with NVE only is allowed. Any sign of fibrosis proliferation is exclusionary
- Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
- Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed
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 |
|---|---|---|
| OTT166Also: nesvategrastParticipants will receive OTT166 ophthalmic solution | Drug | OTT166 Cohort 1, OTT166 Cohort 2 |
| Vehicle controlParticipants will receive vehicle control | Drug | Vehicle control Cohort 1, Vehicle control Cohort 2 |
Primary outcome
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
Time frame: At week 24
To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.
17 secondary outcomes
Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)
Time frame: At week 24
Proportion of Participants Who Developed ASNV
Time frame: At week 24
Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)
Time frame: At week 24
Proportion of Participants Who Developed CI-DME
Time frame: At week 24
The Development of CI-DME
Time frame: At week 24
Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC)
Time frame: At Week 24
Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME
Time frame: From Baseline (Day 1) up to Week 24
Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline
Time frame: At week 24
Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR
Time frame: At week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: From Baseline (Day 1) up to Week 24
Proportion of Participants With Lines Gained/Lost of BCVA
Time frame: From Baseline (Day 1) up to Week 24
Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24
Time frame: From Baseline (Day 1) up to Week 24
Change From Baseline in Central Subfield Thickness (CST)
Time frame: From Baseline (Day 1) up to Week 24
Area Under The Curve (AUC) for Change From Baseline in CST
Time frame: From Baseline (Day 1) up to Week 24
Proportion of Participants Who Met the Objective Rescue Criteria
Time frame: From Baseline (Day 1) up to Week 24
Proportion That Met Objective Rescue Therapy Criteria by Week 24
Time frame: From Baseline (Day 1) up to Week 24
Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Carl Regillo, MD principal investigator
Principal Investigator
68 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTT166 in people with Diabetic Retinopathy, run by OcuTerra Therapeutics, Inc. at 68 sites in 2 countries.
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 7 inclusion and 34 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 9 Aug 2024). 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?
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores (time frame: At week 24). 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 9 Aug 2024.