Treatment of neovascular AMD: Artificial intelligence in real-world setting

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

16 Nov 2020 → ongoing

Decision date (initial)

2025-01-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518482-99-01

EudraCT number

2019-003133-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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).

Conditions and MedDRA coding

neovasclar AMD

Regulatory references

Plan to share IPD

No

IPD plan description

All data remains within the Medical university of Vienna.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. - Adults ≥ 50 years
2. - Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA
3. - Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS
4. - No significant fibrosis or geographic atrophy (GA) involving the fovea
5. - Willingness and ability to comply with study visits and study procedures
6. - Signed informed consent form

Exclusion criteria 15

1. - 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)
2. - Any surgical treatment of the eye within 3 months prior to baseline in the study eye
3. - History of pseudophakic cystoid macular edema (Irvine Gass Syndrome)
4. - 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.)
5. - History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio >0,9
6. - Aphakia in the study eye
7. - Presence of a retinal pigment epithelial tear involving the macula in the study eye
8. - Any concurrent intraocular condition in the study eye (e.g. advanced cataract or diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the twelve-month study period to prevent or treat visual loss that might result from that condition
9. - Active intraocular inflammation (grade trace or above) in the study eye
10. - Active or suspected ocular or periocular infection in the study eye
11. - Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
12. - Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
13. - Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
14. - Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery) during the study period
15. - Presence of corneal decompensation, haze or scaring with an impact on BCVA

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Number of anti-VEGF injections

Secondary endpoints 9

1. - Best-corrected visual acuity (BCVA) assessed by ETDRS Score
2. - Anatomic changes in the macula assessed with OCT (central retinal thickness, fluid volumes in nl, additional morphologic changes)
3. - Formation of geographic-like macular atrophy assessed by fundus photography with special filters
4. - Formation of retinal tears assessed by OCT
5. - Chorioretinal perfusion changes (OCTA)
6. - Perfusion of the neovascular lesion (OCTA, FA)
7. - Changes in macular sensitivity (MP)
8. - Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)
9. - Quality-of-life assessed by questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Ophthalmology and Optometry

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Ophthalmology and Optometry

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications