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

ConditionDiabetic Macular Edema

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAbbVie

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Adult Participants with Diabetic Macular Edema

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

554 Participants

are grouped into 3 trial groups

Group A: Group 1-Dexamethasone implant (DEX-I) Treatment

Group B: Group 2 -aVEGF Treatment

Group C: Group 3 -aVEGF & DEX-I Treatment

Trial outcomes

Primary outcomes

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

Best corrected visual acuity

Time frame

Up to 3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: