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Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial

  • Retinal Disorders
  • Published:
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Abstract

Purpose

To assess the efficacy of a treat-and-extend strategy with intravitreal ranibizumab for radiation-related macular edema.

Methods

Forty eyes with radiation-induced macular edema and decreased visual acuity were enrolled in the phase IIb, prospective clinical trial and randomized into 3 cohorts: (A) monthly ranibizumab, (B) monthly ranibizumab with targeted retinal photocoagulation (TRP), or (C) as-needed ranibizumab and TRP. In year 2, all subjects entered a treat-and-extend protocol for ranibizumab. The primary outcome measure was mean change in early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) from baseline.

Results

Through year 1, the mean change in ETDRS BCVA was significantly different between the three cohorts (p < 0.001); cohort A saw the largest gain with + 4.0 letters. Significant anatomic improvements were also seen in all cohorts. Comparatively, through year 2, cohorts A, B, and C had a mean change in ETDRS BCVA of − 1.9, − 3.9, and + 1.3 letters, respectively; additionally, no significant differences were found in absolute ETDRS BCVA across time (ANOVA, p = 0.123). Overall, 90% of eyes maintained VA 20/200 or better and 33.3% of subjects gained at least one line of vision. There were no significant differences in mean central macular thickness for any cohort compared to baseline (p = 0.09). The presence of retinal hemorrhage and intraretinal exudates stayed consistent from year 1 to year 2 for all cohorts.

Conclusions

Among eyes with radiation-related macular edema, a treat-and-extend regimen with ranibizumab may not result in as many visual and anatomic improvements as monthly injections. However, treat-and-extend still may prevent serious visual complications compared to historical controls.

Trial registration

ClinicalTrials.gov Identifier: NCT02222610

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Data availability

The data discussed in the current manuscript will be available on ClinicalTrials.gov under the associated NCT trial code.

Code of availability

N/A

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Acknowledgements

The authors would also like to acknowledge Guangming Lang for providing significant statistical analyses of the data presented in this manuscript. He has been financially compensated for his contributions.

Funding

This work was supported by Genentech, Inc (San Francisco, CA).

Author information

Authors and Affiliations

  1. Retina Consultants of Texas, Retina Consultants of America, Houston, TX, USA

    Hannah J. Yu, Jose Munoz, Chelsey Moore, Ryan S. Kim & Amy C. Schefler

  2. Texas Retina Associates, Dalla, TX, USA

    Dwain Fuller, Rajiv Anand & Timothy Fuller

  3. McGovern Medical School, Houston, TX, USA

    Ryan S. Kim

  4. Blanton Eye Institute, Houston Methodist Hospital, 6560 Fannin Street, Ste. 750, Houston, TX, 77030, USA

    Amy C. Schefler

Authors
  1. Hannah J. Yu
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  2. Dwain Fuller
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  3. Rajiv Anand
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  4. Timothy Fuller
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  5. Jose Munoz
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  6. Chelsey Moore
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  7. Ryan S. Kim
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  8. Amy C. Schefler
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Consortia

the RRR Study Group

  • Maria E. Bretana
  •  & Karen Diugnan

Corresponding author

Correspondence to Amy C. Schefler.

Ethics declarations

Ethics approval

Institutional Review Board/Ethics Committee approval was prospectively obtained by the Houston Methodist Hospital (Houston, TX, USA).

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

All participants of the current study signed informed consent regarding publishing their data and photographs.

Conflict of interest

Dwain Fuller, Rajiv Anand, and Tim Fuller report investigator funding from Genentech Inc. Amy C. Schefler reports investigator funding and consultant fees from Genentech Inc. All other authors have no financial disclosures to report.

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The sponsor or funding organization had no role in the design or conduct of this research and writing of as well as the decision to submit the article.

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Supplementary file1 (DOC 219 KB)

Supplementary file2 (DOC 53 KB)

Appendix Additional RRR Study Group Members:

Appendix Additional RRR Study Group Members:

Maria E. Bretana1.

Karen Diugnan2.

1Retina Consultants of Texas, Retina Consultants of America, Houston, TX, USA.

2Texas Retina Associates, Dallas, TX, USA.

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Cite this article

Yu, H.J., Fuller, D., Anand, R. et al. Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial. Graefes Arch Clin Exp Ophthalmol 260, 47–54 (2022). https://doi.org/10.1007/s00417-021-05281-2

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  • DOI: https://doi.org/10.1007/s00417-021-05281-2

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