Trial · NCT05409235
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) | 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. | ETDRS letters | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With Lines Gained/Lost of BCVA | 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. | percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24 | 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. | letters*day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Central Subfield Thickness (CST) | 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. | microns | LEAST_SQUARES_MEAN |
| SECONDARY | Area Under The Curve (AUC) for Change From Baseline in CST | 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. | microns*day | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants Who Met the Objective Rescue Criteria | 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. | estimated percentage | NUMBER |
| SECONDARY | Proportion That Met Objective Rescue Therapy Criteria by Week 24 | 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. | estimated rescue percentage | NUMBER |
| SECONDARY | Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered | 24 Weeks | 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 percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline | 24 weeks | 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 |
| OTHER_PRE_SPECIFIED | Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53 | 24 weeks | 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 percentage of participants | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05409235/outcomes