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

F

Federico II University

Status

Completed

Conditions

Radiation Maculopathy

Treatments

Drug: Ranibizumab 0.5Mg/0.05Ml Oph Inj

Study type

Observational

Funder types

Other

Identifiers

NCT04377295
PT1034/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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