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NCT Number: NCT07567833

Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents

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.

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Key information

Conditions

Diabetic Retinal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Anti-VEGF

Primary outcomes

  1. 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)

  2. 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

  3. Change in electroretinography parameter

    Time frame: Baseline to 1 year

    Measured by the RETeval device

  4. Change in reading performance

    Time frame: Baseline to 1 year

    Measured by the MNREAD test

  5. Change in visual field function

    Time frame: Baseline to 1 year

    Measured by Humphrey Visual Field testing

  6. Change in diabetic retinopathy severity

    Time frame: Baseline to 1 year

    Assessed by ultra-widefield (UWF) color fundus photography

  7. Change in retinal vascular pathology

    Time frame: Baseline to 1 year

    Assessed by ultra-widefield fluorescein angiography (UWF-FA)

  8. Change in retinal structure

    Time frame: Baseline to 1 year

    measured by optical coherence tomography (OCT)

  9. Change in retinal microvascular parameter

    Time frame: Baseline to 1 year

    Measured by optical coherence tomography angiography (OCTA)

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Acronym: AS

Important dates

Study start
2026
Primary completion
2027
Study completion
2033
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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