A multicenter, single-arm study using a modified faricimab treat-and-extend regimen in patients with macular edema due to central retinal vein occlusion: RVOSTAR study design protocol

PONE-D-25-46857

Dear Dr. Kondo,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Shinji Kakihara, M.D.,Ph.D.

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PLOS ONE

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2. Thank you for stating the following financial disclosure:

“This study was funded by Chugai Pharmaceutical Co., Ltd., a member of the Roche Group. Chugai Pharmaceutical Co., Ltd. was involved in the study design and preparation of the manuscript. Medical writing assistance was provided by Nilisha Fernando, PhD, of Envision Pharma Group, and funded by Chugai Pharmaceutical Co., Ltd. Envision Pharma Group’s services complied with international guidelines for Good Publication Practice (GPP 2022).”

Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

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3. Thank you for stating the following in the Competing Interests section:

“I have read the journal's policy and the authors of this manuscript have the following competing interests: M.Kondo: financial support from Alcon Japan, Chugai, HOYA, Santen, and Senju; consulting fees from Chugai; royalties from Alcon Japan, Bayer, HOYA, Kowa, Novartis, Otsuka, Santen, and Senju. M.S.: financial support from Bayer, Chugai, Kowa, Novartis, Otsuka, Roche, Santen, and Senju; consulting fees from Bayer, Boehringer Ingelheim, Chugai, Cimic, and Nikki HD. AT: financial support from Novartis, Santen, and Senju; consulting fees from Santen and Senju; renumeration from Bayer, Chugai, Novartis, Santen, and Senju. Y.M.: financial support from Alcon Japan, AMO Japan, Bayer Yakuhin, Canon, Chugai, HOYA, Johnson & Johnson K.K., Novartis, ROHTO, Santen, and Senju. T.K., Y.A., Y.H.: none. J.T., K.I.: employees of Chugai Pharmaceutical Co., Ltd. M.Kamei: financial support from Alcon Japan, Chugai, HOYA, Kowa, Menicon, Otsuka, Santen, Senju, Sony, and Wakamoto; royalties from Alcon Japan, Bayer, Chugai, Daicel, HOYA, Kowa, Novartis, Santen, Senju, Sony, and Wakamoto.”

We note that you received funding from a commercial source: Chugai Pharmaceutical Co., Ltd. M.Kamei

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Additional Editor Comments (optional):

This protocol was reviewed by two reviewers, and both found the study design clear and well organized. I agree with their assessment and see no need for revision. I recommend acceptance as submitted. Thanks

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

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Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

Reviewer #1: This manuscript presents the protocol of a prospective multicenter study (RVOSTAR) evaluating the efficacy of a modified treat-and-extend regimen of faricimab for RVO-ME. The Introduction and Discussion sections provide a clear and well-structured overview of the disease background and the limitations of existing treatments, highlighting the rationale and significance of the study. The Methods section describes the study design, eligibility criteria, and outcome measures in sufficient detail, providing all the essential information expected in a protocol paper.

I believe that no specific revisions are needed, and the manuscript will be very clear and valuable for the readers.

Reviewer #2: This study investigates effective treatments for CRVO-ME. The background and objectives are clearly stated, and the significance of the research is well conveyed.

The structure is highly logical.

The discussion is thorough, and connections to prior research are well demonstrated.

I recommend acceptance of this paper.

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Reviewer #1: No

Reviewer #2: Yes:  Eimi Suzuki

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