NCT07567833 · Jaeb Center for Health Research
Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
(AS)
What this study is about
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 effectiveness.
View original scientific description
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
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).
Primary outcome measures
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Time frame: Baseline to 1 year
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Change in area under the log contrast sensitivity function (AULCSF)
Time frame: Baseline to 1 year
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Change in electroretinography parameter
Time frame: Baseline to 1 year
Measured by the RETeval device
Change in reading performance
Time frame: Baseline to 1 year
Measured by the MNREAD test
Change in visual field function
Time frame: Baseline to 1 year
Measured by Humphrey Visual Field testing
Change in diabetic retinopathy severity
Time frame: Baseline to 1 year
Assessed by ultra-widefield (UWF) color fundus photography
Change in retinal vascular pathology
Time frame: Baseline to 1 year
Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Change in retinal structure
Time frame: Baseline to 1 year
measured by optical coherence tomography (OCT)
Change in retinal microvascular parameter
Time frame: Baseline to 1 year
Measured by optical coherence tomography angiography (OCTA)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Augusta, Georgia
- Boston, Massachusetts
- Detroit, Michigan
- Rochester, Minnesota
- Monroeville, Pennsylvania
- Sewickley, Pennsylvania
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2026 · Source of record for eligibility and locations