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

Jaeb Center for Health Research

Status and phase: Not yet enrolling; Phase 4

Conditions: Diabetic Retinal Disease

Treatments: Drug: Anti-Vascular Endothelial Growth Factor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07567833

Protocol AS (1)

UG1EY014231 (U.S. NIH Grant/Contract)

Details and patient eligibility

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 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Mild center-involved diabetic macular edema

Active Comparator group

Description:

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

Treatment:

Drug: Anti-Vascular Endothelial Growth Factor

Moderate Center-involved diabetic macular edema

Active Comparator group

Description:

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

Treatment:

Drug: Anti-Vascular Endothelial Growth Factor

Severe Center-involved diabetic macular edema

Active Comparator group

Description:

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

Treatment:

Drug: Anti-Vascular Endothelial Growth Factor