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

Completed

• Conditions: Radiation Maculopathy

• Registration Number: NCT04377295
• Lead Sponsor: Federico II University

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.

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 Timeline

• Study Start: 2012-10-30
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-03
• Last Update Submitted: 2020-05-03
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (%)