Twenty-Four Month Results of Intravitreal Ranibizumab for Macular Edema after Branch Retinal Vein Occlusion: Visual Outcomes and Resolution of Macular Edema

ABSTRACT

Purpose: To report 24-month results after one intravitreal ranibizumab (IVR) injection followed by pro re nata (PRN) dosing for macular edema (ME) after branch retinal vein occlusion (BRVO).

Methods: Eyes with BRVO met the followings were included: 77 letters or less best-corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] score) and central retinal thickness (CRT) of 250 µm or more. IVR injection was performed followed by a PRN regimen. The retreatment criteria included visual loss of five or more ETDRS letters compared with the previous visit, 250 µm or more of CRT, or presence of residual or recurrent ME including the parafoveal lesions. The primary outcome measures were the BCVA changes at month 12 and month 24 from baseline, and the secondary outcomes were changes in CRT, resolution of ME, the number of IVR injections, and changes of nonperfused areas (NPAs).

Results: Twenty eyes of 20 patients (5 men, 15 women; mean age, 68.2 years) were enrolled. The mean BCVAs (ETDRS letters) at baseline, month 12, and month 24 were 62.0, 80.2, and 80.9, respectively. The mean ETDRS letters gains were 18.3 and 19.0 at month 12 and month 24, respectively. The percentages of patients with Snellen equivalent BCVAs of 20/20 or better at month 12 and month 24 were 75% and 70%, respectively. The mean CRTs at baseline, month 12, and month 24 were 480, 252, and 272 μm, respectively. Forty percent of all eyes had complete resolution of ME. The mean number of IVR injections was 8.3 times, which gradually decreased over time. The NPA change in either Zone 1 or Zone 2 was not significant during the follow-up. No adverse side effects were observed.

Conclusion: IVR injection followed by a PRN regimen provided pretty good visual outcomes at month 24.

Keywords:

• Branch retinal vein occlusion
• macular edema
• ranibizumab

Acknowledgments

We thank Fumie Shibuya, Yasuyo Fukuda, Sayaka Oshio, Satomi Izumi, and Miho Takeuchi from Nagoya City University Graduate School of Medical Sciences for their help with data collection.

Compliance with Ethical Standards

Disclosure Statement

YH has received research grants from the Japan Society for the Promotion of Science (18K09416) and was supported by the Eye Research Foundation of the Aged. NS has received research grants from the Japan Society for the Promotion of Science (19K18884). TY has received research grants from the Japan Society for the Promotion of Science (19K09954). YO has received research grants from the Japan Society for the Promotion of Science (18H02958).

Each of coauthors, MI, YY, MK, and MY, declares that he/she has no conflict of interest.

Ethical Approval

The Institutional Review Board of the Nagoya City University Graduate School of Medical Sciences approved the study protocol (No. 00000891-3). The clinical trial was registered in ClinicalTrials.gov (ID: NCT02478515). All patients provided written informed consent for participation in the study. The research methods and analyses adhered to the tenets of the Declaration of Helsinki.

Author Contributions

MI, YH, YY, MK, and NS collected and analyzed the data. YH wrote the main manuscript text. TY, MY, and YO supervised the work. All authors reviewed the manuscript.

Additional information

Funding

This study was partially supported by Novartis Pharma (Tokyo, Japan) [not applicable].