Radiation MaculopathyNCT04377295
Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab
An observational study of Radiation Maculopathy, run by Federico II University.
Trial summary
This study evaluates the retinal and vascular features in patients with radiation maculopathy 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 40 to 60 years
- Conditions the study is for
- Radiation Maculopathy
- What is being tested?
- Ranibizumab 0.5Mg/0.05Ml Oph Inj
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2012to 30 Oct 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 40 to 60 years
- All sexes
- Adult
Study population: The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 40 years
- diagnosis of radiation maculopathy
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
Who cannot join
- age younger than 40 years
- No diagnosis of radiation maculopathy
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
About this study
Official title: Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy
This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.
Read the detailed description
The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.
Ranibizumab is a vascular endothelial growth factor antagonist and it represents 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 intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.
- Conditions
- Radiation Maculopathy
- Being tested
- Ranibizumab 0.5Mg/0.05Ml Oph Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5Mg/0.05Ml Oph InjDrug
All patients received one monthly intravitreal injection of Ranibizumab (0.5 mg/0.05 ml) through the pars plana under aseptic conditions until maximum visual acuity was achieved and there was no sign of macular edema at optical coherence tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography (OCT).
The parameter analyzed by OCT was: Central Macular Thickness (micron).
Measured: one year
Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography angiography (OCTA).
The parameter analyzed by OCTA was: retinal vessel density (%)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start30 Oct 2012
- Primary completion1 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation MaculopathyStudies 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
- 40 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
- NCT04377295
- Sponsor's protocol ID
- PT1034/20
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 6 May 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 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy
- ClinicalTrials.gov ID
- NCT04377295
- Acronym / sponsor ID
- PT1034/20
- Conditions
- Radiation Maculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 30 Oct 2012 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 6 May 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 with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.
Detailed description
The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.
Ranibizumab is a vascular endothelial growth factor antagonist and it represents 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 intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 40 years
- diagnosis of radiation maculopathy
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
Key exclusion criteria (4 listed)
- age younger than 40 years
- No diagnosis of radiation maculopathy
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
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 0.5Mg/0.05Ml Oph InjAll patients received one monthly intravitreal injection of Ranibizumab (0.5 mg/0.05 ml) through the pars plana under aseptic conditions until maximum visual acuity was achieved and there was no sign of macular edema at optical coherence tomography | Drug | – |
Primary outcome
Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab
Time frame: one year
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography (OCT). The parameter analyzed by OCT was: Central Macular Thickness (micron).
Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab
Time frame: one year
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was: retinal 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 6 May 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
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Maculopathy, run by Federico II University.
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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab (time frame: one year). 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 6 May 2020.