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Choroidal Thickness Changes After Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration

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Abstract

Background

The results regarding changes of choroidal thickness following intravitreal ranibizumab injections in the literature are controversial. Vascular endothelial growth factor A is implicated in pathogenesis of neovascular age-related macular degeneration (AMD). The suspected unchanged choroidal layer thickness after intravitreal injections of ranibizumab suggests a possible protection of the outer blood–retinal barrier in the human eye.

Objective

The aim was to evaluate choroidal thickness following the first administration of the study drug ranibizumab into the eyes of naïve wet AMD patients (nAMD).

Methods

In this open label, 3-month, prospective, single-center, interventional, single-arm pilot study, 20 nAMD eyes were included and underwent three consecutive monthly injections of ranibizumab (0.5 mg/0.05 ml). Vital signs (i.e., blood pressure and pulse), ophthalmic examinations, intraocular pressure, best correct visual acuity and subfoveal choroidal thickness as examined with optical coherence tomography using enhanced depth imaging (OCT-EDI) were assessed at each visit. All patients were evaluated at baseline and at 15, 30 60 and 90 days after intravitreal injection. Ten eyes with fibrotic AMD lesions were evaluated as the control group.

Results

In all eyes, the choroidal thicknesses (µm) exhibited no significant changes from the baseline visit to the visits at 15, 30, 60 and 90 days post-injection (P > 0.05). The intravitreal treatment with ranibizumab was well tolerated, and no adverse events were registered.

Conclusion

Choroidal thickness appeared to be unmodified following the intravitreal injection of ranibizumab into nAMD eyes. Intravitreal ranibizumab injections probably elicit a pharmacologic effect only in the choroidal neovascularization and not in the choroid circulation under neovascular lesions.

Clinical Trials Eudract Registration #: 2013-005091-17.

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Acknowledgments

We would like to thank the ethical committee of the Catholic University Sacred Hearth of Rome for their assistance in the realization of this project. We would like to thank Novartis for their support.

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Authors and Affiliations

  1. Catholic University of Sacred Heart, “A. Gemelli” Foundation, Largo A. Gemelli, 00168, Rome, Italy

    Angelo Maria Minnella, Matteo Federici, Benedetto Falsini, Lucilla Barbano, Gloria Gambini, Angela Lanza, Aldo Caporossi & Maria Cristina Savastano

Authors
  1. Angelo Maria Minnella
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  2. Matteo Federici
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  3. Benedetto Falsini
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  4. Lucilla Barbano
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  5. Gloria Gambini
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  6. Angela Lanza
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  7. Aldo Caporossi
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  8. Maria Cristina Savastano
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Corresponding author

Correspondence to Angelo Maria Minnella.

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Funding

No sources of funding were used to assist in the preparation of this manuscript. Drug and partial financial support for the study were provided by Novartis.

Ethical approvals

The study was performed in accordance with the current version of the Declaration of Helsinki [52nd World Medical Association (WMA) General Assembly, Edinburgh, Scotland, October 2000]. The trial was conducted in agreement with the guidelines of the International Conference on Harmonization (ICH) on Good Clinical Practice (GCP). The study was performed in compliance with Italian Medicines Agency (AIFA) requirements. The study was granted full regulatory approval from the AIFA on 18 December 2013. The protocol was issued the EudraCT number 2013-005091-17. The study was granted full approval from the Catholic University Ethical Committee on 28 November 2013 under protocol number 21699/13.

Informed consent

All patients provided written informed consent after detailed explanation about the aim of the study.

Conflict of interest

No conflicts of interest exist for any author. The authors Angelo Maria Minnella, Matteo Federici, Benedetto Falsini, Lucilla Barbano, Gloria Gambini, Angela Lanza, Aldo Caporossi and Maria Cristina Savastano declare they have no conflicts of interest directly related to this study.

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Minnella, A.M., Federici, M., Falsini, B. et al. Choroidal Thickness Changes After Intravitreal Ranibizumab for Exudative Age-Related Macular Degeneration. BioDrugs 30, 353–359 (2016). https://doi.org/10.1007/s40259-016-0179-0

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  • DOI: https://doi.org/10.1007/s40259-016-0179-0

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