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

Radiation Maculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04377295
• Other study ID #: PT1034/20
• Status: Completed
• Start date: October 30, 2012
• Est. completion date: October 30, 2019

Study information

• Verified date: May 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2019
• Est. primary completion date: October 1, 2019
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiation Maculopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	one year
Primary	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 (%)	one year