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NCT Number: NCT07604545

A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema

This study is to assess the use of Artificial intellignce (AI) to predict eye treatment changes in adult participants with diabetic macular edema (DME).

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously untreated Diabetic macular edema (DME) Participants.
  • Baseline macular edema ≥350 microns confirmed on Spectralis Standard deviation (SD)-Optical coherence tomography (OCT) or equivalent.
  • Baseline Best corrected visual acuity (BCVA) between 23 and 78 Early treatment diabetic retinopathy study (ETDRS) letters (between 20/32 and 20/230 Snellen).

Exclusion criteria

  • History of eyes with previous intravitreal or laser treatment for DME.
  • History of eyes with previous intraocular or periocular corticosteroid for DME.
  • History eyes with other macular disease, causing visual reduction or disturbance.

Treatment and study plan

Primary outcomes

  1. Proportion of participants gaining ≥10 Early treatment diabetic retinopathy study (ETDRS) letters Best Corrected Visual Acuity (BCVA)

    Time frame: Up to 3 months

    Best corrected visual acuity

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Shirlaw

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Predictive Value of OCT Inflammatory Biomarkers in DME Using AI Analysis

Acronym: OPTIMAL-3

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 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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