Coats DiseaseNCT04310631
Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab
An observational study of Coats Disease, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography Read more about this study
- Who is it for?
- Ages 19 to 30 years, men only
- Conditions the study is for
- Coats Disease
- What is being tested?
- Ranibizumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2016to 31 Dec 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 19 to 30 years
- Men only
- No healthy volunteers
- Adult
Study population: The participans were older than 18 years with diagnosis of Coats disease. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 18 years
- diagnosis of Coats disease
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
- absence of diabetes
Who cannot join
- age younger than 18 years
- No diagnosis of Coats disease
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
- presence of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography Findings After Intravitreal Ranibizumab in Patients With Coats Disease
This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography
Read the detailed description
Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment.
Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Ranibizumab in Coats disease.
- Conditions
- Coats Disease
- Being tested
- Ranibizumab Injection
- Medical subject headings
- Retinal Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab InjectionDrug
Ranibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography (OCT).
The parameters analyzed by OCT were:
Central Macular Thickness (micron), Subfoveal Choroidal Thickness (micron)
Measured: Three months
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography angiography (OCTA)
The parameters analyzed by OCTA were:
retinal vessel density (%), choriocapillaris vessel density (%)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coats DiseaseStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 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 UniversityDaniela Montorio, Study director, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310631
- Sponsor's protocol ID
- PT1003/20
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 17 Mar 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Findings After Intravitreal Ranibizumab in Patients With Coats Disease
- ClinicalTrials.gov ID
- NCT04310631
- Acronym / sponsor ID
- PT1003/20
- Conditions
- Coats Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Mar 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.
This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography
Detailed description
Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment.
Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Ranibizumab in Coats disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The participans were older than 18 years with diagnosis of Coats disease. They did not present other ophthalmological diseases.
Key inclusion criteria (5 listed)
- age older than 18 years
- diagnosis of Coats disease
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
- absence of diabetes
Key exclusion criteria (5 listed)
- age younger than 18 years
- No diagnosis of Coats disease
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
- presence of diabetes
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 |
|---|---|---|
| Ranibizumab InjectionRanibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections | Drug | – |
Primary outcome
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
Time frame: Three months
The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography (OCT). The parameters analyzed by OCT were: Central Macular Thickness (micron), Subfoveal Choroidal Thickness (micron)
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab
Time frame: Three months
The effectiveness of Ranibizumab injections for treating Coats disease using optical coherence tomography angiography (OCTA) The parameters analyzed by OCTA were: retinal vessel density (%), choriocapillaris vessel density (%)
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 17 Mar 2020.
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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.
Gilda Cennamo principal investigator
Federico II University
Daniela Montorio study director
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 Coats Disease, 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 5 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 17 Mar 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?
Study of retinal and vascular features in Coats disease after intravitreal injections of Ranibizumab (time frame: Three months). The study lists 2 primary outcomes in all. 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 17 Mar 2020.