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

Predictive Value of OCT Inflammatory Biomarkers in DME Using AI Analysis

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07604545

Acronym

OPTIMAL-3

Enrollment

Registered

2026-05-22

Start date

2026-05-30

Completion date

2027-03-01

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants gaining ≥10 Early treatment diabetic retinopathy study (ETDRS) letters Best Corrected Visual Acuity (BCVA)	Up to 3 months	Best corrected visual acuity

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results