- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04377295
Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab
Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age older than 40 years
- diagnosis of radiation maculopathy
- treatment-naïve with Ranibizumab
- absence of other vitreoretinal and vascular retinal diseases
Exclusion Criteria:
- age younger than 40 years
- No diagnosis of radiation maculopathy
- previous treatments with Ranibizumab
- presence of vitreoretinal and vascular retinal diseases
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
one year
|
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 (%) |
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT1034/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiation Maculopathy
-
Shields, Shields and AssociatesUnknownUveal Melanoma | Radiation Retinopathy | Radiation MaculopathyUnited States
-
Larkin Community HospitalCompletedAdverse Effect of Radiation Therapy
-
Arman MashayekhiAllerganTerminatedMacular Edema | Uveal Melanoma | Radiation Retinopathy | Cystoid Macular Edema | Radiation MaculopathyUnited States
-
Kyorin UniversityCompleted
-
University Hospital Inselspital, BerneCompletedAge Related MaculopathySwitzerland
-
Glostrup University Hospital, CopenhagenCompletedHealthy | Diabetic MaculopathyDenmark
-
University of JenaCompleted
-
University of JenaCompletedAge Related MaculopathyGermany
-
Osaka UniversityHuman Genome Center, Institute of Medical Science, University of TokyoCompletedAge Related Macular Degeneration | Neovascular MaculopathyJapan
-
Wake Forest University Health SciencesWithdrawn
Clinical Trials on Ranibizumab 0.5Mg/0.05Ml Oph Inj
-
EyePoint Pharmaceuticals, Inc.Active, not recruitingWet Age-related Macular DegenerationUnited States
-
Seoul St. Mary's HospitalUnknownPolypoidal Choroidal VasculopathyKorea, Republic of
-
EyePoint Pharmaceuticals, Inc.Not yet recruitingDiabetic Macular Edema
-
Dongyang People's HospitalRecruiting
-
Especialistas en Retina Medica y Quirurgica Grupo...Centro de Retina Medica y Quirurgica S.C.CompletedDiabetic Macular EdemaArgentina, Mexico
-
Hanscom, Thomas, M.D.Genentech, Inc.CompletedCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionUnited States
-
Novartis PharmaceuticalsTerminatedDiabetes | Macular Degeneration | Macular EdemaFrance
-
NovartisCompletedChoroidal NeovascularisationUnited Kingdom
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityCompletedChoroidal NeovascularizationChina
-
Novartis PharmaceuticalsCompletedAge-related Macular Degeneration | Choroidal NeovascularizationKorea, Republic of, Croatia, Germany, India, Russian Federation, Turkey, United Kingdom, Egypt, Israel, Belgium, Denmark, Hungary, Slovenia, Spain, Switzerland, Italy, Portugal, Slovakia, Chile