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Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting

ConditionExudative Macular Degeneration
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-100
SponsorMedical University of Vienna

About this trial

The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥ 50 years

Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA

Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS

No significant fibrosis or geographic atrophy (GA) involving the fovea

Disqualifiers

Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)

Any surgical treatment of the eye within 3 months prior to baseline in the study eye

History of pseudophakic cystoid macular edema (Irvine Gass Syndrome)

History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 0, or a history of post-operative complications within the last 12 months preceding Visit 0 in the study eye (uveitis, cyclitis etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • anti-VEGF agent

    Drug

    All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator. Should the Investigators decision differ from the study protocol, the reason will be indicated in the CRF.

  • anti-VEGF agent

    Drug

    All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Cohort 1 - QuantitativeExperimental treatment 1 intervention
Group B: Cohort 2 - QualitativeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of injections

Number of injections necessary within study period

Time frame
12 months

Secondary outcomes

1

Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score

Longitudinal changes within each group in ETDRS-BCVA and quantitative anatomic measurements in the macula assessed with noninvasive imaging

Time frame
12 months
2

Macular fluid volumes

Changes in total amount of fluid in nanoliters within the central millimeter assessed with automated quantitative fluid measurement on noninvasive OCT imaging.

Time frame
12 months
3

Formation of geographic-like macular atrophy

Formation of geographic-like macular atrophy assessed by fundus photography with specials filters

Time frame
12 months
4

Formation of retinal tears

Formation of retinal tears assessed by OCT

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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