Trial · NCT05409235
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) | From Baseline (Day 1) up 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 Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. A higher score represents better visual function. |
| Secondary | Proportion of Participants With Lines Gained/Lost of BCVA | From Baseline (Day 1) up to Week 24 | 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. |
| Secondary | Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24 | From Baseline (Day 1) up 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. |
| Secondary | Change From Baseline in Central Subfield Thickness (CST) | From Baseline (Day 1) up to Week 24 | 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). |
| Secondary | Area Under The Curve (AUC) for Change From Baseline in CST | From Baseline (Day 1) up to Week 24 | To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by OCT. |
| Secondary | Proportion of Participants Who Met the Objective Rescue Criteria | From Baseline (Day 1) up to 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. |
| Secondary | Proportion That Met Objective Rescue Therapy Criteria by Week 24 | From Baseline (Day 1) up to 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. |
| Secondary | Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered | 24 Weeks | 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. |
| Other | Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline | 24 weeks | A pre-specified sub group analysis of the NPDR population (DRSS 47 or 53) for the development of a VTC defined as worse than mild PDR, CI-DME or ASNV. The reported data include the use of imputation according to the primary estimand as described in the protocol. |
| Other | Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53 | 24 weeks | A measure of the ability to prevent CI-DME in participants with NPDR treated with OTT166. The proportion of patients that develop CI-DME (defined as new fluid in patients with no fluid at baseline or CST \> 325 microns) by week 24. This is a pre-specified sub group analysis and excludes the participants in the DRSS 61B stratum. The reported data include the use of imputation according to the primary estimand as described in the protocol. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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