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Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

2026年9月3日 更新者：Regenerative Ocular Immunobiologics LLC

A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

30

段階

  • フェーズ 3

アクセスの拡大

利用可能 臨床試験外。 拡張アクセス記録をご覧ください。

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Beverly Hills、California、アメリカ、90210
        • 募集
        • Beverly Hills Institute of Ophthalmology
        • コンタクト：
        • 主任研究者：
          • Jillian Chong, MD
      • Beverly Hills、California、アメリカ、90211
        • 募集
        • Beverly Hills Optometry
        • コンタクト：
          • Kambiz Silani, OD
          • 電話番号：310-659-2020
        • コンタクト：
        • 主任研究者：
          • Kambiz Silani, OD
    • Florida
      • Palm Harbor、Florida、アメリカ、34684
        • まだ募集していません
        • Regenerative Ocular Immunobiologics, LLC.
        • コンタクト：
        • コンタクト：
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Eyewell, LLC.
        • コンタクト：
        • 主任研究者：
          • Kristen Brown, OD
      • Boston、Massachusetts、アメリカ、02494
        • 募集
        • BostonSight
        • コンタクト：
        • 主任研究者：
          • Daniel C. Brocks, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Age 18 years or older.
  • Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.
  • Investigator determines the participant is medically stable and appropriate for study participation.
  • Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.
  • UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.
  • Modified Oxford Corneal Staining Score of at least 1 in at least one eye.
  • Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.
  • Written informed consent obtained before study procedures.
  • Willing and able to comply with study visits, study treatment, and protocol requirements.
  • Background therapies stable for at least 30 days before Baseline.

Exclusion Criteria:

  • Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.
  • Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.
  • Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.
  • Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.
  • Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.
  • Participation in another investigational study within 30 days before Screening or concurrent enrollment.
  • Pregnancy or breastfeeding.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Vehicle Controlled
生物学的：Matching vehicle control
Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
実験的：Active Study Drug
生物学的：d-MAPPS™ Ophthalmic Solution
Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score
時間枠：Baseline to Day 90 (±5 days)
Corneal fluorescein staining will be assessed in the prespecified study eye using the Modified Oxford grading scale. Scores range from 0 to 5, where 0 represents no corneal staining and higher scores represent progressively greater staining. A decrease from Baseline indicates improvement.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score
時間枠：Baseline to Day 90 (±5 days)
The Ocular Surface Disease Index (OSDI) will assess ocular symptoms and their effect on vision-related functioning. Total scores range from 0 to 100, with higher scores representing greater symptom burden. A decrease from Baseline indicates improvement.
Baseline to Day 90 (±5 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With a ≥1-Grade Decrease in Modified Oxford Corneal Staining Score
時間枠：Baseline to Day 90 (±5 days)
The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the prespecified study eye. Scores range from 0 to 5, with higher scores indicating greater corneal staining. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥13-Point Decrease in OSDI Total Score
時間枠：Baseline to Day 90 (±5 days)
The proportion of participants achieving a decrease of at least 13 points from Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score. Scores range from 0 to 100, with higher scores indicating greater symptom burden. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Tear Break-Up Time (TBUT)
時間枠：Baseline to Day 90 (±5 days)
Change from Baseline to Day 90 in tear break-up time, measured in seconds, in the prespecified study eye. An increase indicates improvement in tear-film stability.
Baseline to Day 90 (±5 days)
Percentage of Participants Receiving Protocol-Defined Rescue Therapy
時間枠：Randomization through Day 90
The proportion of participants receiving at least one administration of protocol-defined rescue therapy during the randomized treatment period.
Randomization through Day 90
Time to First Administration of Protocol-Defined Rescue Therapy
時間枠：Randomization through Day 90
Time from randomization to the first administration of protocol-defined rescue therapy.
Randomization through Day 90
Percentage of Participants With Protocol-Defined Treatment Failure
時間枠：Randomization through Day 90
The proportion of participants experiencing treatment failure, defined as initiation of protocol-defined rescue therapy, permanent discontinuation of assigned study treatment because it is not providing adequate benefit, or withdrawal from all further study participation because of worsening ocular GVHD signs or symptoms.
Randomization through Day 90
Change From Baseline to Day 90 in Supportive Efficacy Measures in the Fellow Eye
時間枠：Baseline to Day 90 (±5 days)
Supportive analyses will evaluate change from Baseline to Day 90 separately for protocol-defined measures collected in the fellow eye, including the Modified Oxford Corneal Staining score, superficial punctate keratitis (SPK) severity, and tear break-up time (TBUT). Modified Oxford scores range from 0 to 5, with higher scores indicating greater corneal staining; a decrease indicates improvement. Lower SPK severity indicates improvement. TBUT is measured in seconds; an increase indicates improved tear-film stability. No composite score will be calculated.
Baseline to Day 90 (±5 days)
Percentage of Participants With Modified Oxford Corneal Staining Score Grade 0 at Day 90
時間枠：Day 90 (±5 days)
The proportion of participants with a Modified Oxford Corneal Staining Score of Grade 0 in the prespecified study eye at Day 90. Scores range from 0 to 5, with higher scores indicating greater corneal staining and a worse outcome. Grade 0 indicates no corneal staining.
Day 90 (±5 days)
Change From Baseline to Day 90 in Superficial Punctate Keratitis (SPK) Severity
時間枠：Baseline to Day 90 (±5 days)
Change from Baseline to Day 90 in the protocol-defined Superficial Punctate Keratitis (SPK) Severity Grade in the prespecified study eye. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in Superficial Punctate Keratitis (SPK) Severity
時間枠：Baseline to Day 90 (±5 days)
The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the protocol-defined Superficial Punctate Keratitis (SPK) Severity Grade in the prespecified study eye. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Percentage of Participants With Superficial Punctate Keratitis (SPK) Severity of 0 at Day 90
時間枠：Day 90 (±5 days)
The proportion of participants with a Superficial Punctate Keratitis (SPK) Severity Grade of 0 in the prespecified study eye at Day 90. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. Grade 0 indicates complete resolution of SPK.
Day 90 (±5 days)
Change From Baseline to Day 90 in NIH Eye Score
時間枠：Baseline to Day 90 (±5 days)
Change from Baseline to Day 90 in the National Institutes of Health (NIH) Eye Score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in NIH Eye Score
時間枠：Baseline to Day 90 (±5 days)
The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the National Institutes of Health (NIH) Eye Score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A decrease indicates improvement.
Baseline to Day 90 (±5 days)
Percentage of Participants With No Worsening in NIH Eye Score at Day 90
時間枠：Baseline to Day 90 (±5 days)
The proportion of participants whose National Institutes of Health (NIH) Eye Score at Day 90 is equal to or lower than their Baseline score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A lower score indicates improvement, while an unchanged score indicates no worsening.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in UNC Dry Eye Management Scale Visual Analog Scale Score
時間枠：Baseline to Day 90 (±5 days)
Change from Baseline to Day 90 in the University of North Carolina Dry Eye Management Scale (UNC DEMS) Visual Analog Scale score. Scores range from 1 to 10, with higher scores indicating more severe dry-eye symptoms, greater effects on daily life, and a worse outcome. A decrease indicates improvement.
Baseline to Day 90 (±5 days)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Regenerative Ocular Immunobiologics LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年3月31日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月17日

最初の投稿 (実際)

2026年8月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月4日

QC基準を満たした最後の更新が送信されました

2026年9月3日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • IND 30066-PIVOT

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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