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

NCT07567833 | Not Yet Recruiting Phase 4

• 2 other identifiers: Protocol AS (1)UG1EY014231
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinal Disease

Outcome Measures

Primary Outcomes (9)

• Change in multifocal pupillographic objective perimetry (mfPOP) response delays

  mfPOP response delays measured using the Objective Field Analyzer (OFA)

  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

  Baseline to 1 year

• Change in electroretinography parameter

  Measured by the RETeval device

  Baseline to 1 year

• Change in reading performance

  Measured by the MNREAD test

  Baseline to 1 year

• Change in visual field function

  Measured by Humphrey Visual Field testing

  Baseline to 1 year

• Change in diabetic retinopathy severity

  Assessed by ultra-widefield (UWF) color fundus photography

  Baseline to 1 year

• Change in retinal vascular pathology

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

  Baseline to 1 year

• Change in retinal structure

  measured by optical coherence tomography (OCT)

  Baseline to 1 year

• Change in retinal microvascular parameter

  Measured by optical coherence tomography angiography (OCTA)

  Baseline to 1 year

Study Arms (3)

Mild center-involved diabetic macular edema

ACTIVE COMPARATOR

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

Moderate Center-involved diabetic macular edema

ACTIVE COMPARATOR

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 Center-involved diabetic macular edema

ACTIVE COMPARATOR

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

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).

Also known as: Anti-VEGF

Mild center-involved diabetic macular edema; Moderate Center-involved diabetic macular edema; Severe Center-involved diabetic macular edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2033
• Last Updated: May 5, 2026

Record last verified: 2026-04