Trial · NCT03197870
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
NCT03197870, Phase 2, Completed, EyePoint Pharmaceuticals, Inc.; results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR). Trials, record NCT03197870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03197870
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
- NCT number
- NCT03197870
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 167 participants, actual
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Conditions
- Nonproliferative Diabetic Retinopathy
- Interventions
- AKB-9778, Placebo
- First posted
- 2017-06-23
- Last updated
- 2023-06-27
- Results first posted
- 2023-06-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps | Baseline to Week 48 | Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12 |
| Secondary | Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 | Baseline to Week 48 | Worsening of Diabetic Retinopathy Severity Score (DRSS) severity of ≥ 2 steps in study eyes at Week 48 (compared to placebo group) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
| Secondary | Mean Change From Baseline in DRSS in the Study Eye at Week 48 | Week 48 | Mean change from baseline in Diabetic Retinopathy Severity Score (DRSS) in the study eye at week 48. Note: Observed values at Week 48 instead of change from baseline values at Week 48 were analyzed Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
| Secondary | Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48. | Baseline to Week 48 | Summary of subjects with an improvement or worsening in the study eye Diabetic Retinopathy Severity Score (DRSS) of ≥ 3 steps at Week 48 (compared to placebo) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
| Secondary | Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes) | Treatment Period - 12 months (48 weeks) | Subjects with Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients with Non-qualified Fellow Eye and \>=3 Steps Improvement on the Person Scale for Patients with Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
| Secondary | Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes) | Treatment Period - 12 months (48 weeks) | Subjects With Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and \>=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
| Secondary | Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data. | Treatment Period - 12 months (48 weeks) | Summary of patients developing center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or PDR-related outcomes during treatment period based on Clinical Data. Based on either clinical data or central image reading center evaluation. |
| Secondary | Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation | Treatment Period - 12 months (48 weeks) | Summary of Subjects Developing Center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or Worsening of \>=2 Steps Diabetic Retinopathy Severity Scale (DRSS) at Week 48 Based on Central Image Reading Center Evaluation - Study Eyes Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps | Baseline to Week 48 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | eyes | COUNT_OF_UNITS |
| SECONDARY | Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 | Baseline to Week 48 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | study eyes | COUNT_OF_UNITS |
| SECONDARY | Mean Change From Baseline in DRSS in the Study Eye at Week 48 | Week 48 | Modified Intent-to-Treat Population With at Least 1 Scheduled Post-Baseline Measure (LOCF) | score on a scale | MEAN |
| SECONDARY | Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48. | Baseline to Week 48 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | study eyes | COUNT_OF_UNITS |
| SECONDARY | Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes) | Treatment Period - 12 months (48 weeks) | Modified Intent-to-Treat Population with at least 1 scheduled Post-Baseline Measure (LOCF) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes) | Treatment Period - 12 months (48 weeks) | Modified Intent-to-Treat Population with at least 1 scheduled Post-Baseline Measure (LOCF) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data. | Treatment Period - 12 months (48 weeks) | mITT Population With ≥1 Scheduled Post-Baseline Measure (LOCF) | study eyes | COUNT_OF_UNITS |
| SECONDARY | Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation | Treatment Period - 12 months (48 weeks) | Modified Intent-to-Treat Population With at Least 1 Scheduled Post-Baseline Measure (LOCF) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps | Razuprotafib 15mg Twice Daily | 0 | eyes | ||
| Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps | Razuprotafib 15mg Daily | 5 | eyes | ||
| Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps | Placebo Twice Daily | 2 | eyes | ||
| Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 | AKB-9778 15mg Daily | 5 | study eyes | ||
| Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 | AKB-9778 15mg Twice Daily | 6 | study eyes | ||
| Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 | Placebo Twice Daily | 4 | study eyes | ||
| Mean Change From Baseline in DRSS in the Study Eye at Week 48 | AKB-9778 15mg Daily | 5.0 | Standard Deviation 1.15 | score on a scale | |
| Mean Change From Baseline in DRSS in the Study Eye at Week 48 | AKB-9778 15mg Twice Daily | 4.9 | Standard Deviation 1.55 | score on a scale | |
| Mean Change From Baseline in DRSS in the Study Eye at Week 48 | Placebo Twice Daily | 4.8 | Standard Deviation 1.35 | score on a scale | |
| Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48. | AKB-9778 15mg Daily | Worsening ≥3 steps | 3 | study eyes |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Razuprotafib 15mg Twice Daily | 55 | |
| Overall Study | STARTED | Razuprotafib 15mg Daily | 55 | |
| Overall Study | STARTED | Placebo Twice Daily | 57 | |
| Overall Study | COMPLETED | Razuprotafib 15mg Twice Daily | 41 | |
| Overall Study | COMPLETED | Razuprotafib 15mg Daily | 45 | |
| Overall Study | COMPLETED | Placebo Twice Daily | 51 | |
| Overall Study | NOT COMPLETED | Razuprotafib 15mg Twice Daily | 14 | |
| Overall Study | NOT COMPLETED | Razuprotafib 15mg Daily | 10 | |
| Overall Study | NOT COMPLETED | Placebo Twice Daily | 6 |
Source ClinicalTrials.gov
Adverse events228
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 | Nasopharyngitis | Infections and infestations | Razuprotafib 15mg Twice Daily | 5 | 55 | 5 |
| other | Nasopharyngitis | Infections and infestations | Razuprotafib 15mg Daily | 4 | 55 | 5 |
| other | Nasopharyngitis | Infections and infestations | Placebo Twice Daily | 8 | 57 | 11 |
| other | Urinary tract infection | Infections and infestations | Razuprotafib 15mg Twice Daily | 7 | 55 | 8 |
| other | Urinary tract infection | Infections and infestations | Razuprotafib 15mg Daily | 4 | 55 | 4 |
| other | Urinary tract infection | Infections and infestations | Placebo Twice Daily | 2 | 57 | 2 |
| other | Influenza | Infections and infestations | Razuprotafib 15mg Twice Daily | 3 | 55 | 3 |
| other | Influenza | Infections and infestations | Razuprotafib 15mg Daily | 5 | 55 | 5 |
| other | Influenza | Infections and infestations | Placebo Twice Daily | 4 | 57 | 4 |
| other | Sinusitis | Infections and infestations | Razuprotafib 15mg Twice Daily | 2 | 55 | 2 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Razuprotafib 15mg Twice Daily | 0 | 55 |
| Total, all-cause mortality | Razuprotafib 15mg Daily | 0 | 55 |
| Total, all-cause mortality | Placebo Twice Daily | 1 | 57 |
| Total, other adverse events | Razuprotafib 15mg Twice Daily | 55 | 55 |
| Total, other adverse events | Razuprotafib 15mg Daily | 55 | 55 |
| Total, other adverse events | Placebo Twice Daily | 57 | 57 |
| Total, serious adverse events | Razuprotafib 15mg Twice Daily | 8 | 55 |
| Total, serious adverse events | Razuprotafib 15mg Daily | 6 | 55 |
| Total, serious adverse events | Placebo Twice Daily | 5 | 57 |
Source ClinicalTrials.gov
Papers0
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03197870
GET https://conductscience.org/api/trials/v1/NCT03197870/results?page=2