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OpenTrials
Completed

NCT Number: NCT04377295

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab 0.5Mg/0.05Ml Oph Inj

Drug

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

Primary outcomes

  1. Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab

    Time frame: 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).

  2. Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab

    Time frame: 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 (%)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.