Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab

May 3, 2020 updated by: Gilda Cennamo, Federico II University

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2012

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 3, 2020

Last Verified

May 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

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.

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