Diabetic Retinal Disease
Conditions
Brief summary
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.
Interventions
DRUGAnti-Vascular Endothelial Growth Factor
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).
Sponsors
Jaeb Center for Health Research
National Eye Institute (NEI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * Age ≥18 years * Diagnosed with Type 1 or Type 2 diabetes * Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters) * At least 1 eye with CI-DME requiring treatment * Able and willing to provide informed consent. Key
Exclusion criteria
* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina. * Previous treatment of any kind for diabetic retinopathy or DME * Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis) * History of rhegmatogenous retinal detachment or macular hole * History of vitrectomy * Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in multifocal pupillographic objective perimetry (mfPOP) response delays | Baseline to 1 year | mfPOP response delays measured using the Objective Field Analyzer (OFA) |
| Change in area under the log contrast sensitivity function (AULCSF) | Baseline to 1 year | AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system |
| Change in electroretinography parameter | Baseline to 1 year | Measured by the RETeval device |
| Change in reading performance | Baseline to 1 year | Measured by the MNREAD test |
| Change in visual field function | Baseline to 1 year | Measured by Humphrey Visual Field testing |
| Change in diabetic retinopathy severity | Baseline to 1 year | Assessed by ultra-widefield (UWF) color fundus photography |
| Change in retinal vascular pathology | Baseline to 1 year | Assessed by ultra-widefield fluorescein angiography (UWF-FA) |
| Change in retinal structure | Baseline to 1 year | measured by optical coherence tomography (OCT) |
| Change in retinal microvascular parameter | Baseline to 1 year | Measured by optical coherence tomography angiography (OCTA) |
Outcome results
None listed