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

Federico II University40 enrolled

Overview

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.

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

Conditions

Radiation Maculopathy

Interventions

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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 (%)

Time frame: one year

Data from ClinicalTrials.gov

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