Neovascular Age-related Macular DegenerationNCT03833830
Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment
An observational study of Neovascular Age-related Macular Degeneration, run by Dr. med. Katja Hatz at 1 site in Switzerland.
Trial summary
Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Optical Coherence Tomography angiography (OCTA)
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jan 2019to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the study.
Who may be able to join
- To be eligible for participation, patients will be required to
- have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or <5 times (shortterm treatment eyes).
- give written consent to participation
Who cannot join
- diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment
- history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc.
- history of papillary disease which might interfere with interpretation of peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV, papillar drusen, optic nerve neuritis, papillar edema etc.
- inability to perform OCTA examination of sufficient quality.
- history of any side effects of Tropicamide eye drops
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross Sectional Study Assessing the Perifoveal and Peripapillar Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment - Pilotstudy
Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).
Read the detailed description
Main outcome parameters are:
- Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement)
- Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement).
- Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement)
- Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg) (*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.
- Being tested
- Optical Coherence Tomography angiography (OCTA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography angiography (OCTA)Diagnostic test
There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections).
| Study group | Role | What they receive |
|---|---|---|
| longterm treatment group | previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections Receives: Diagnostic Test: Optical Coherence Tomography angiography (OCTA) | |
| shortterm treatment group | previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections Receives: Diagnostic Test: Optical Coherence Tomography angiography (OCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
Measured: baseline V0
Secondary outcomes (4)
Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
Measured: baseline V0
Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
Measured: baseline V0
weight
weight meassurements in kg
Measured: baseline V0
height
height meassurements in cm
Measured: baseline V0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start7 Jan 2019
- Primary completion2 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Katja Hatz
- Sponsor type
- University, hospital or other
- Collaborators
- Cenaug Foundation
- Responsible party
- Sponsor-investigator, Dr. med. Katja Hatz, Vista Klinik
- Investigators
- Katja Hatz, MD, Principal investigator, Vista Klinik Binningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833830
- Sponsor's protocol ID
- OCTA 2018-02043
- Status last verified
- Sep 2019
- First submitted
- 27 Dec 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: if necessary on request
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study Assessing the Perifoveal and Peripapillar Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment - Pilotstudy
- ClinicalTrials.gov ID
- NCT03833830
- Acronym / sponsor ID
- OCTA 2018-02043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr. med. Katja HatzUniversity, hospital or other
- Collaborators
- Cenaug Foundation
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 7 Feb 2019 (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.
Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal anti-VEGF application might temporarily increase intraocular pressure due to a volume effect. It remains unclear if repeated injections might have an impact on retinal capillary perfusion. Therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal Anti-VEGF treatment and patients who recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).
Detailed description
Main outcome parameters are:
- Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement)
- Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by OCTA (single measurement).
- Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement)
- Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg) (*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| longterm treatment group | – | Diagnostic Test: Optical Coherence Tomography angiography (OCTA)previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections |
| shortterm treatment group | – | Diagnostic Test: Optical Coherence Tomography angiography (OCTA)previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the study.
Key inclusion criteria (3 listed)
- To be eligible for participation, patients will be required to
- have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal injections either for at least 20 times (longterm treatment eyes) or <5 times (shortterm treatment eyes).
- give written consent to participation
Key exclusion criteria (5 listed)
- diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment
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 |
|---|---|---|
| Optical Coherence Tomography angiography (OCTA)There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections). | Diagnostic test | longterm treatment group, shortterm treatment group |
Primary outcome
Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups
Time frame: baseline V0
in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
4 secondary outcomes
Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)
Time frame: baseline V0
Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)
Time frame: baseline V0
weight
Time frame: baseline V0
height
Time frame: baseline V0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Undecided. if necessary on request
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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. This study is not recruiting at the moment.
Katja Hatz, MD principal investigator
Vista Klinik Binningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Dr. med. Katja Hatz at 1 site in Switzerland.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 Oct 2019. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups (time frame: baseline V0). 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 1 Oct 2019.