Exudative Macular DegenerationPhase 4NCT05093374
Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
A Phase 4 study testing anti-VEGF agent in people with Exudative Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Exudative Macular Degeneration
- What is being tested?
- anti-VEGF agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Willingness and ability to comply with study visits and study procedures
- Signed informed consent form
Who cannot join
- 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.)
- 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
- Aphakia in the study eye
Show all 15Show fewer
- Presence of a retinal pigment epithelial tear involving the macula in the study eye
- 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
- Active intraocular inflammation (grade trace or above) in the study eye
- Active or suspected ocular or periocular infection in the study eye
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
- Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
- Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- 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
- Presence of corneal decompensation, haze or scaring with an impact on BCVA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Medical University of Vienna, Austria
Vienna, State of Vienna, 1090
Stefan Sacu, Associate Professor, MD
About this study
Official title: Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
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).
Read the detailed description
Neovascular age-related macular degeneration (nAMD) is a significant burden to health care systems in industrialized countries. Due to its chronic nature, continuous follow-up and treatment is needed to prevent significant loss of visual function in patients with nAMD.
Vascular endothelial growth factor (VEGF) plays a major role in the pathomechanisms of nAMD and large multicenter trials have shown that intravitreal application of substances which intercept the VEGF pathway can interrupt the progression of nAMD and improve the visual outcome.
As every single injection bears the risk of sight-threatening complications and increases the financial burden to health care providers, several studies have tested different treatment regimens, to decrease the number of applicated injections without compromising the gains in visual acuity. Thereby, strict protocols have been compared to flexible "as needed" regimens (pro re nata, PRN) and regimens with proactive increments of injection intervals (treat and extend, T\&E).
Studies have indicated that the outcome of anti-VEGF treatment is better in standardized clinical trials than in so-called "real world settings". This is explained by tight exclusion criteria of sponsored trials, the shorter follow-up time and the small number of patients that are treated per center, resulting in a better standard of care.
PRN as well as T\&E management showed disadvantages such as significant less vision gain in PRN and possible over treatment in T\&E.
Recently, additional treatment criteria were described to improve the patients care.
Advances in diagnostic precision by SD-OCT using automated algorithms to accurately measure fluid volumes in all compartments are solid tools to determine disease activity. They allow to precisely quantifying the impact of therapeutic parameters on disease activity.
Multicenter study analyses have shown that the amount of intraretinal fluid has a significant effect on vision outcome. Subretinal fluid or Pigmentepithelial detachment have been described to be less important. These findings were the basis for designing an efficient point-of-care management. Automated quantification of the fluid amount using artificial intelligence (AI) may serve as a reliable and objective method to determine the personalized point-of-care.
To prove the efficacy of point-of-care management, prospective studies in real-world settings are required. More data is required to assess the outcome of real-world settings and find ways to improve treatment results, when larger amounts of patients are treated and less resources are available for decision making.
The purpose of this study is to implement quantitative assessment tools for the treatment of 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
- Exudative Macular Degeneration
- Being tested
- anti-VEGF agent
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-VEGF agentDrug
Also called Cohort 1 - Quantitative
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 agentDrug
Also called Cohort 2 - Qualitative
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Quantitative | Experimental | Patients will undergo monthly follow-up visits including fluid quantification and will be retreated in case of active disease, which is defined as:
* reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity compared to previous visit
* new sub-retinal hemorrhage
* increase >50% in IRF volume in the central 1 mm compared to month 2
* increase > 50 % in SRF volume in the central 1 mm compared to month 2
* in case of NO intra- and/or subretinal fluid (=less than 10nl) in visits 2 or 3, retreat if fluid in central 1mm ≥ 10nl
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. Receives: Drug: anti-VEGF agent |
| Cohort 2 - Qualitative | Active comparator | Patients will undergo monthly follow-up visits. Treatment will be performed in case of active disease, which is defined as:
* reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity
* new sub-retinal hemorrhage
* any fluid
In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment. Receives: Drug: anti-VEGF agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of injections
Number of injections necessary within study period
Measured: 12 months
Secondary outcomes (8)
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
Measured: 12 months
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.
Measured: 12 months
Formation of geographic-like macular atrophy
Formation of geographic-like macular atrophy assessed by fundus photography with specials filters
Measured: 12 months
Formation of retinal tears
Formation of retinal tears assessed by OCT
Measured: 12 months
Chorioretinal perfusion
Chorioretinal perfusion (OCTA, ICG)
Measured: 12 months
Perfusion of the neovascular lesion
Perfusion of the neovascular lesion (OCTA, FA and ICG, SS)
Measured: 12 months
Quality of Life by Questionnaire
Quality of Life assessed by Questionnaire NEI - VFQ 25
Measured: 12 months
Central retinal thickness
Measurement of central retinal thickness in micrometers on noninvasive OCT imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1: Quantitative assessment: Treatment decision with support of artificial intelligence software. (n=145) Cohort 2: Qualitative assessment: Treatment decision without support of artificial intelligence software. (n=145)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Sacu, Medical University of Vienna
- Investigators
- Stefan Sacu, MD, Principal investigator, Medical University of Vienna, Dept. of Ophthalmology and Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093374
- Sponsor's protocol ID
- 1672_2019
- Status last verified
- Nov 2024
- First submitted
- 12 Jun 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
- ClinicalTrials.gov ID
- NCT05093374
- Acronym / sponsor ID
- 1672_2019
- Conditions
- Exudative Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Neovascular age-related macular degeneration (nAMD) is a significant burden to health care systems in industrialized countries. Due to its chronic nature, continuous follow-up and treatment is needed to prevent significant loss of visual function in patients with nAMD.
Vascular endothelial growth factor (VEGF) plays a major role in the pathomechanisms of nAMD and large multicenter trials have shown that intravitreal application of substances which intercept the VEGF pathway can interrupt the progression of nAMD and improve the visual outcome.
As every single injection bears the risk of sight-threatening complications and increases the financial burden to health care providers, several studies have tested different treatment regimens, to decrease the number of applicated injections without compromising the gains in visual acuity. Thereby, strict protocols have been compared to flexible "as needed" regimens (pro re nata, PRN) and regimens with proactive increments of injection intervals (treat and extend, T\&E).
Studies have indicated that the outcome of anti-VEGF treatment is better in standardized clinical trials than in so-called "real world settings". This is explained by tight exclusion criteria of sponsored trials, the shorter follow-up time and the small number of patients that are treated per center, resulting in a better standard of care.
PRN as well as T\&E management showed disadvantages such as significant less vision gain in PRN and possible over treatment in T\&E.
Recently, additional treatment criteria were described to improve the patients care.
Advances in diagnostic precision by SD-OCT using automated algorithms to accurately measure fluid volumes in all compartments are solid tools to determine disease activity. They allow to precisely quantifying the impact of therapeutic parameters on disease activity.
Multicenter study analyses have shown that the amount of intraretinal fluid has a significant effect on vision outcome. Subretinal fluid or Pigmentepithelial detachment have been described to be less important. These findings were the basis for designing an efficient point-of-care management. Automated quantification of the fluid amount using artificial intelligence (AI) may serve as a reliable and objective method to determine the personalized point-of-care.
To prove the efficacy of point-of-care management, prospective studies in real-world settings are required. More data is required to assess the outcome of real-world settings and find ways to improve treatment results, when larger amounts of patients are treated and less resources are available for decision making.
The purpose of this study is to implement quantitative assessment tools for the treatment of neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Cohort 1: Quantitative assessment: Treatment decision with support of artificial intelligence software. (n=145) Cohort 2: Qualitative assessment: Treatment decision without support of artificial intelligence software. (n=145)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Quantitative | Experimental | Drug: anti-VEGF agentPatients will undergo monthly follow-up visits including fluid quantification and will be retreated in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity compared to previous visit * new sub-retinal hemorrhage * increase >50% in IRF volume in the central 1 mm compared to month 2 * increase > 50 % in SRF volume in the central 1 mm compared to month 2 * in case of NO intra- and/or subretinal fluid (=less than 10nl) in visits 2 or 3, retreat if fluid in central 1mm ≥ 10nl 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. |
| Cohort 2 - Qualitative | Active comparator | Drug: anti-VEGF agentPatients will undergo monthly follow-up visits. Treatment will be performed in case of active disease, which is defined as: * reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity * new sub-retinal hemorrhage * any fluid In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Willingness and ability to comply with study visits and study procedures
Key exclusion criteria (15 listed)
- 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.)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-VEGF agentAlso: Cohort 1 - QuantitativeAll 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. | Drug | Cohort 1 - Quantitative |
| anti-VEGF agentAlso: Cohort 2 - QualitativeAll 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. | Drug | Cohort 2 - Qualitative |
Primary outcome
Number of injections
Time frame: 12 months
Number of injections necessary within study period
8 secondary outcomes
Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score
Time frame: 12 months
Macular fluid volumes
Time frame: 12 months
Formation of geographic-like macular atrophy
Time frame: 12 months
Formation of retinal tears
Time frame: 12 months
Chorioretinal perfusion
Time frame: 12 months
Perfusion of the neovascular lesion
Time frame: 12 months
Quality of Life by Questionnaire
Time frame: 12 months
Central retinal thickness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Exudative Macular Degeneration
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4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
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Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
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Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Sacu, MD principal investigator
Medical University of Vienna, Dept. of Ophthalmology and Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anti-VEGF agent in people with Exudative Macular Degeneration, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefan Sacu, MD (+43 1 40400 ext. 79620, stefan.sacu@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of injections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.