Trial · NCT04265261
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
NCT04265261, Phase 2, Completed, Hoffmann-La Roche; results first posted 2024-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy. Trials, record NCT04265261. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04265261
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
- NCT number
- NCT04265261
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 139 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Diabetic Retinopathy
- Interventions
- Placebo, RG7774
- First posted
- 2020-02-11
- Last updated
- 2024-09-25
- Other registries' IDs
- eudract:2019-002067-10
- Results first posted
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye | Week 36 | The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy) |
| Primary | Percentage of Participants With Adverse Events (AEs) | Up to 1 year (baseline through follow-up period) | |
| Secondary | Time-to-Event for Vision-Threatening DR in the Study Eye | Up to Day 277 | Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event. |
| Secondary | Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Week 36 | This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event. |
| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 | Baseline; Week 36 | BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye | Week 36 | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Percentage of participants | NUMBER |
| SECONDARY | Time-to-Event for Vision-Threatening DR in the Study Eye | Up to Day 277 | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Days | NUMBER |
| SECONDARY | Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Week 36 | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36 | Baseline; Week 36 | The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to. | Number of letters | MEAN |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | Up to 1 year (baseline through follow-up period) | The Safety population is defined as all participants who give informed consent, receive at least one dose of study medication (active or placebo) and were grouped according to the actual treatment received. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye | Placebo | 7.89 | 95% Confidence Interval 2.72 to 20.8 | Percentage of participants | |
| Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye | Vicasinabin 30 mg QD | 9.52 | 95% Confidence Interval 3.77 to 22.07 | Percentage of participants | |
| Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye | Vicasinabin 200 mg QD | 5.71 | 95% Confidence Interval 1.58 to 18.61 | Percentage of participants | |
| Time-to-Event for Vision-Threatening DR in the Study Eye | Placebo | NA | 95% Confidence Interval 257.0 to NA | Days | |
| Time-to-Event for Vision-Threatening DR in the Study Eye | Vicasinabin 30 mg QD | 267.0 | 95% Confidence Interval 254.0 to NA | Days | |
| Time-to-Event for Vision-Threatening DR in the Study Eye | Vicasinabin 200 mg QD | NA | 95% Confidence Interval 260.0 to NA | Days | |
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Placebo | New ASNV | 0 | 95% Confidence Interval 0.0 to 9.4 | Percentage of participants |
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Vicasinabin 30 mg QD | New ASNV | 0 | 95% Confidence Interval 0.0 to 9.2 | Percentage of participants |
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Vicasinabin 200 mg QD | New ASNV | 0 | 95% Confidence Interval 0.0 to 10.2 | Percentage of participants |
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye | Placebo | New PDR | 0 | 95% Confidence Interval 0.0 to 9.4 | Percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 47 | |
| Overall Study | STARTED | Vicasinabin 30 mg QD | 48 | |
| Overall Study | STARTED | Vicasinabin 200 mg QD | 44 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | COMPLETED | Vicasinabin 30 mg QD | 43 | |
| Overall Study | COMPLETED | Vicasinabin 200 mg QD | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Vicasinabin 30 mg QD | 5 | |
| Overall Study | NOT COMPLETED | Vicasinabin 200 mg QD | 8 |
Source ClinicalTrials.gov
Adverse events78
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 | Diabetic retinal oedema | Eye disorders | Placebo | 3 | 47 | 3 |
| other | Diabetic retinal oedema | Eye disorders | Vicasinabin 30 mg QD | 8 | 48 | 13 |
| other | Diabetic retinal oedema | Eye disorders | Vicasinabin 200 mg QD | 6 | 43 | 7 |
| other | Diabetic retinopathy | Eye disorders | Placebo | 3 | 47 | 3 |
| other | Diabetic retinopathy | Eye disorders | Vicasinabin 30 mg QD | 5 | 48 | 5 |
| other | Diabetic retinopathy | Eye disorders | Vicasinabin 200 mg QD | 1 | 43 | 2 |
| other | Vitreous haemorrhage | Eye disorders | Placebo | 1 | 47 | 2 |
| other | Vitreous haemorrhage | Eye disorders | Vicasinabin 30 mg QD | 3 | 48 | 3 |
| other | Vitreous haemorrhage | Eye disorders | Vicasinabin 200 mg QD | 2 | 43 | 3 |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 47 | 4 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 47 |
| Total, all-cause mortality | Vicasinabin 30 mg QD | 0 | 48 |
| Total, all-cause mortality | Vicasinabin 200 mg QD | 0 | 44 |
| Total, other adverse events | Placebo | 13 | 47 |
| Total, other adverse events | Vicasinabin 30 mg QD | 21 | 48 |
| Total, other adverse events | Vicasinabin 200 mg QD | 15 | 43 |
| Total, serious adverse events | Placebo | 8 | 47 |
| Total, serious adverse events | Vicasinabin 30 mg QD | 3 | 48 |
| Total, serious adverse events | Vicasinabin 200 mg QD | 5 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39802207 | DERIVED |
Source PubMed
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/NCT04265261
GET https://conductscience.org/api/trials/v1/NCT04265261/results?page=2