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

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT04377295

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Maculopathy	Drug: Ranibizumab 0.5Mg/0.05Ml Oph Inj

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

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Oct 30, 2012

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 30, 2019

Outcome Measures

Primary Outcome Measures

Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab [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 [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 (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Federico II University

Investigators

Principal Investigator: Gilda Cennamo, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilda Cennamo, Principal Investigator, Federico II University

ClinicalTrials.gov Identifier:

NCT04377295

Other Study ID Numbers:

PT1034/20

First Posted:

May 6, 2020

Last Update Posted:

May 6, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macular Degeneration

Ranibizumab

Study Results

No Results Posted as of May 6, 2020