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

Conditions

• Diabetic Retinal Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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).

Study Details

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.

Key Dates

First listed

May 5, 2026

Start date

Jul 31, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Active Comparator: Mild center-involved diabetic macular edema
  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
• Active Comparator: Moderate Center-involved diabetic macular edema
  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
• Active Comparator: Severe Center-involved diabetic macular edema
  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

Primary Outcome Measure

Change in multifocal pupillographic objective perimetry (mfPOP) response delays [ Time Frame: Baseline to 1 year ]

Locations (6)

Find similar trials in Augusta, GA

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• Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes
  Recruiting · Jaeb Center for Health Research · Augusta, Georgia