Age Related Macular DegenerationNCT04689789
OCTA and Retinal Angiomatous Proliferation
An observational study of Age Related Macular Degeneration, run by Federico II University at 1 site in Italy.
Trial summary
To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- optical coherence tomography angiography
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 20 Dec 2020
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The participans were older than 65 years with diagnosis of age-related macular degeneration and in particular retinal angiomatous proliferation and reticular pseudodrusen. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 65 years
- diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT-A images.
Who cannot join
- age older than 80 years
- absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT-A images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Quantitative Deep Capillary Plexus in the Pathogenesis of Retinal Angiomatous Proliferation: an Optical Coherence Tomography Angiography Study.
To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP.
Read the detailed description
Retinal vascular anomalous complex represents a distinct form of neovascularization in patients with age-related macular degeneration.
The study investigated the changes in retinal vascular network using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.
- Conditions
- Age Related Macular Degeneration
- Being tested
- optical coherence tomography angiography
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography angiographyDiagnostic test
optical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network
| Study group | Role | What they receive |
|---|---|---|
| Patients with RAP | Patients with previous diagnosis of retinal angiomatous proliferation Receives: Diagnostic Test: optical coherence tomography angiography | |
| Patients with reticular pseudodrusen | Patients with previous diagnosis of reticular pseudodrusen Receives: Diagnostic Test: optical coherence tomography angiography | |
| Control group | Healthy eyes without actual and previous ocular diseases Receives: Diagnostic Test: optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls
The parameters analyzed by optical coherence tomography angiography were: vessel density of superficial capillary plexus and deep capillary plexus
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Sep 2019
- Primary completion1 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689789
- Sponsor's protocol ID
- 2912/20
- Status last verified
- Dec 2020
- First submitted
- 29 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Quantitative Deep Capillary Plexus in the Pathogenesis of Retinal Angiomatous Proliferation: an Optical Coherence Tomography Angiography Study.
- ClinicalTrials.gov ID
- NCT04689789
- Acronym / sponsor ID
- 2912/20
- Conditions
- Age Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 30 Dec 2020 (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.
To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP.
Detailed description
Retinal vascular anomalous complex represents a distinct form of neovascularization in patients with age-related macular degeneration.
The study investigated the changes in retinal vascular network using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with RAP | – | Diagnostic Test: optical coherence tomography angiographyPatients with previous diagnosis of retinal angiomatous proliferation |
| Patients with reticular pseudodrusen | – | Diagnostic Test: optical coherence tomography angiographyPatients with previous diagnosis of reticular pseudodrusen |
| Control group | – | Diagnostic Test: optical coherence tomography angiographyHealthy eyes without actual and previous ocular diseases |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The participans were older than 65 years with diagnosis of age-related macular degeneration and in particular retinal angiomatous proliferation and reticular pseudodrusen. They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 65 years
- diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT-A images.
Key exclusion criteria (4 listed)
- age older than 80 years
- absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT-A images.
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 angiographyoptical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network | Diagnostic test | Control group, Patients with RAP, Patients with reticular pseudodrusen |
Primary outcome
The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls
Time frame: 15 months
The parameters analyzed by optical coherence tomography angiography were: vessel density of superficial capillary plexus and deep capillary plexus
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 30 Dec 2020.
Related trials for Age Related Macular Degeneration
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingObservational study
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
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.
Gilda Cennamo principal investigator
Federico II University
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 Age Related Macular Degeneration, run by Federico II University at 1 site in Italy.
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 4 inclusion and 4 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 30 Dec 2020. 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 Italy. 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?
The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls (time frame: 15 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 30 Dec 2020.