Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY014231 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
Not provided
Not provided
Not provided
Not provided
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild center-involved diabetic macular edema | Active Comparator | Eyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
|
| Moderate Center-involved diabetic macular edema | Active Comparator | Eyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
|
| Severe Center-involved diabetic macular edema | Active Comparator | Severe CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Vascular Endothelial Growth Factor | Drug | All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in multifocal pupillographic objective perimetry (mfPOP) response delays | mfPOP response delays measured using the Objective Field Analyzer (OFA) | Baseline to 1 year |
| Change in area under the log contrast sensitivity function (AULCSF) | AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system | Baseline to 1 year |
| Change in electroretinography parameter | Measured by the RETeval device | Baseline to 1 year |
| Change in reading performance | Measured by the MNREAD test | Baseline to 1 year |
| Change in visual field function | Measured by Humphrey Visual Field testing | Baseline to 1 year |
| Change in diabetic retinopathy severity | Assessed by ultra-widefield (UWF) color fundus photography | Baseline to 1 year |
| Change in retinal vascular pathology | Assessed by ultra-widefield fluorescein angiography (UWF-FA) | Baseline to 1 year |
| Change in retinal structure | measured by optical coherence tomography (OCT) |
Not provided
Not provided
Key inclusion criteria:
Key exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline to 1 year |
| Change in retinal microvascular parameter | Measured by optical coherence tomography angiography (OCTA) | Baseline to 1 year |