A Phase 4 interventional study of Anti-Vascular Endothelial Growth Factor in Diabetic Retinal Disease, sponsored by Jaeb Center for Health Research. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Jaeb Center for Health Research · Phase 4, Interventional, and Other
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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.
Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key inclusion criteria:
Key exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Anti-Vascular Endothelial Growth Factor
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
Drug: Anti-Vascular Endothelial Growth Factor
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
Drug: Anti-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).
Also known as: Anti-VEGF
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Time frame: 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
Time frame: Baseline to 1 year
Change in electroretinography parameter
Measured by the RETeval device
Time frame: Baseline to 1 year
Change in reading performance
Measured by the MNREAD test
Time frame: Baseline to 1 year
Change in visual field function
Measured by Humphrey Visual Field testing
Time frame: Baseline to 1 year
Change in diabetic retinopathy severity
Assessed by ultra-widefield (UWF) color fundus photography
Time frame: Baseline to 1 year
Change in retinal vascular pathology
Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Time frame: Baseline to 1 year
Change in retinal structure
measured by optical coherence tomography (OCT)
Time frame: Baseline to 1 year
Change in retinal microvascular parameter
Measured by optical coherence tomography angiography (OCTA)
Time frame: Baseline to 1 year
Started Jul 2026 (actual). Primary completion is estimated for Dec 2027, 17 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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