NCT07604545

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
May 2026Mar 2027

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

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

    Best corrected visual acuity

    Up to 3 months

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Participants with Diabetic Macular Edema

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

Andrew Shirlaw

CONTACT

844-663-3742andrew.shirlaw@abbvie.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

May 30, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05