A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema (OPTIMAL-3)

May 18, 2026 updated by: AbbVie

Predictive Value of OCT Inflammatory Biomarkers in DME Using AI Analysis

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

554

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Participants with Diabetic Macular Edema

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1-Dexamethasone implant (DEX-I) Treatment
Participants treated with dexamethasone implant (DEX-I).
Group 2 -aVEGF Treatment
Participants treated with anti-Vascular Endothelial Growth Factor (aVEGF).
Group 3 -aVEGF & DEX-I Treatment
Participants initially treated with aVEGF and then switched to DEX-I at 3-5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H25-796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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