NCT04377295

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

Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: —

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.

Conditions

• Radiation Maculopathy

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.5Mg/0.05Ml Oph Inj	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

Timeline

• Start date: 2012-10-30
• Primary completion: 2019-10-01
• Completion: 2019-10-30
• First posted: 2020-05-06
• Last updated: 2020-05-06