Recruiting

Observational Study

Sponsor:

Jaeb Center for Health Research

Code:

NCT07567833

Conditions

Diabetic Retinal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-Vascular Endothelial Growth Factor

Study Details

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

Study ID

NCT07567833

Start date

Jul 31, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

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 measure

  • Change in multifocal pupillographic objective perimetry (mfPOP) response delays [ Time Frame: Baseline to 1 year ]
  • Change in area under the log contrast sensitivity function (AULCSF) [ Time Frame: Baseline to 1 year ]
  • Change in electroretinography parameter [ Time Frame: Baseline to 1 year ]
  • Change in reading performance [ Time Frame: Baseline to 1 year ]
  • Change in visual field function [ Time Frame: Baseline to 1 year ]
  • Change in diabetic retinopathy severity [ Time Frame: Baseline to 1 year ]
  • Change in retinal vascular pathology [ Time Frame: Baseline to 1 year ]
  • Change in retinal structure [ Time Frame: Baseline to 1 year ]
  • Change in retinal microvascular parameter [ Time Frame: Baseline to 1 year ]

Central Contacts and Locations

Locations

Southeast Retina Center, P.C.

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Dennis M Marcus, MD

709-650-0061amitchell@southeastretina.com

Boston Medical Center Corporation

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Steven D Ness, MD

617-414-4020sreevardhan.alluri@bmc.org

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Paul A Edwards, MD

313-874-9167mdakhil1@hfhs.org

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Andrew J. Barkmeier, MD

507-538-8119Taylor.Laura2@mayo.edu

Retina-Vitreous Consultants, Inc.

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Shripaad Y Shukla, MD

412-683-5300merlottil@retinapittsburgh.com

Pittsburgh Clinical Trial Consortium

Recruiting

Sewickley, Pennsylvania, United States, 15143

Contacts

Leanne T. Labriola, DO, MBA

412-301-5326franco@pghtrials.com

More Information

Sponsor

Jaeb Center for Health Research

Last update posted

Sep 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Jaeb Center for Health Research on 2026-09-18.