Trial · NCT05409235
Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
NCT05409235, Phase 2, Completed, OcuTerra Therapeutics, Inc.; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nesvategrast (OTT166) in Diabetic Retinopathy (DR). Trials, record NCT05409235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05409235
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
- NCT number
- NCT05409235
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 225 participants, actual
- Lead sponsor
- OcuTerra Therapeutics, Inc.
- Conditions
- Diabetic Retinopathy
- Interventions
- OTT166, Vehicle control
- First posted
- 2022-06-08
- Last updated
- 2024-08-09
- Results first posted
- 2024-08-09
- Limitations and caveats
- \[Not specified\]
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores | 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. |
| Secondary | Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above) | At week 24 | 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. |
| Secondary | Proportion of Participants Who Developed ASNV | At week 24 | 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. |
| Secondary | Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above) | At week 24 | 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. |
| Secondary | Proportion of Participants Who Developed CI-DME | At week 24 | 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. |
| Secondary | The Development of CI-DME | At week 24 | 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. |
| Secondary | Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC) | At Week 24 | 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. |
| Secondary | Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME | From Baseline (Day 1) up to Week 24 | 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. |
| Secondary | Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline | At week 24 | 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. |
| Secondary | Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR | At week 24 | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores | At week 24 | All participants randomized received at least one dose of study drug which is the Intent to Treat (ITT) population for the study. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated improvement percentage | NUMBER |
| SECONDARY | Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above) | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated risk percentage | NUMBER |
| SECONDARY | Proportion of Participants Who Developed ASNV | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated risk percentage | NUMBER |
| SECONDARY | Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above) | At week 24 | ITT Population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Developed CI-DME | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated risk percentage | NUMBER |
| SECONDARY | The Development of CI-DME | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC) | At Week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated risk percentage | NUMBER |
| SECONDARY | Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME | From Baseline (Day 1) up to Week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | median time to event (days) | MEDIAN |
| SECONDARY | Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR | At week 24 | ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined. | estimated improvement percentage | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores | OTT166 Cohort 1 | 12.187 | 90% Confidence Interval 5.557 to 18.816 | estimated improvement percentage | |
| Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores | OTT166 Cohort 2 | 12.263 | 90% Confidence Interval 5.297 to 19.229 | estimated improvement percentage | |
| Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores | Vehicle Control Combined | 13.311 | 90% Confidence Interval 6.260 to 20.361 | estimated improvement percentage | |
| Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above) | OTT166 Cohort 1 | 12.467 | 90% Confidence Interval 6.105 to 18.828 | estimated risk percentage | |
| Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above) | OTT166 Cohort 2 | 15.316 | 90% Confidence Interval 8.158 to 22.473 | estimated risk percentage | |
| Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above) | Vehicle Control Combined | 9.405 | 90% Confidence Interval 3.503 to 15.307 | estimated risk percentage | |
| Proportion of Participants Who Developed ASNV | OTT166 Cohort 1 | 4.200 | 90% Confidence Interval 0.285 to 8.115 | estimated risk percentage | |
| Proportion of Participants Who Developed ASNV | OTT166 Cohort 2 | 4.487 | 90% Confidence Interval 0.288 to 8.686 | estimated risk percentage | |
| Proportion of Participants Who Developed ASNV | Vehicle Control Combined | 6.068 | 90% Confidence Interval 1.243 to 10.892 | estimated risk percentage | |
| Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above) | OTT166 Cohort 1 | 13 | 90% Confidence Interval 7.46 to 20.75 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTT166 Cohort 1 | 75 | |
| Overall Study | STARTED | OTT166 Cohort 2 | 76 | |
| Overall Study | STARTED | Vehicle Control Cohort 1 | 38 | |
| Overall Study | STARTED | Vehicle Control Cohort 2 | 36 | |
| Overall Study | COMPLETED | OTT166 Cohort 1 | 70 | |
| Overall Study | COMPLETED | OTT166 Cohort 2 | 65 | |
| Overall Study | COMPLETED | Vehicle Control Cohort 1 | 34 | |
| Overall Study | COMPLETED | Vehicle Control Cohort 2 | 30 | |
| Overall Study | NOT COMPLETED | OTT166 Cohort 1 | 5 | |
| Overall Study | NOT COMPLETED | OTT166 Cohort 2 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events152
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Punctate keratitis | Eye disorders | OTT166 Cohort 1 | 10 | 75 | |
| other | Punctate keratitis | Eye disorders | OTT166 Cohort 2 | 12 | 76 | |
| other | Punctate keratitis | Eye disorders | Vehicle Control Cohort 1 | 3 | 38 | |
| other | Punctate keratitis | Eye disorders | Vehicle Control Cohort 2 | 3 | 36 | |
| other | Diabetic retinopathy | Eye disorders | OTT166 Cohort 1 | 5 | 75 | |
| other | Diabetic retinopathy | Eye disorders | OTT166 Cohort 2 | 3 | 76 | |
| other | Diabetic retinopathy | Eye disorders | Vehicle Control Cohort 1 | 3 | 38 | |
| other | Diabetic retinopathy | Eye disorders | Vehicle Control Cohort 2 | 3 | 36 | |
| other | Cataract | Eye disorders | OTT166 Cohort 1 | 3 | 75 | |
| other | Cataract | Eye disorders | OTT166 Cohort 2 | 4 | 76 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTT166 Cohort 1 | 0 | 75 |
| Total, all-cause mortality | OTT166 Cohort 2 | 0 | 76 |
| Total, all-cause mortality | Vehicle Control Cohort 1 | 0 | 38 |
| Total, all-cause mortality | Vehicle Control Cohort 2 | 0 | 36 |
| Total, other adverse events | OTT166 Cohort 1 | 36 | 75 |
| Total, other adverse events | OTT166 Cohort 2 | 35 | 76 |
| Total, other adverse events | Vehicle Control Cohort 1 | 13 | 38 |
| Total, other adverse events | Vehicle Control Cohort 2 | 17 | 36 |
| Total, serious adverse events | OTT166 Cohort 1 | 6 | 75 |
| Total, serious adverse events | OTT166 Cohort 2 | 6 | 76 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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