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A Study to Determine the Safety and Efficacy of NT-501 With M-CHFM

2026年10月30日 更新者：Neurotech Pharmaceuticals

A Multicenter Study to Determine the Safety and Efficacy of NT-501 Utilizing the Medica Membrane in Macular Telangiectasia Type 2 (MacTel), Including a Randomized Comparative Expansion Cohort

The overall purpose of this global, multicenter, two cohort, central image evaluator masked study is to characterize the clinical safety and efficacy of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM) for the treatment of MacTel and to evaluate whether its safety profile and efficacy are comparable to those of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This Phase 3 study consists of two cohorts:

  • Cohort 1 (Extension): Includes participants previously enrolled under the original protocol who received NT-501 (M-CHFM) and will continue follow-up. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason.
  • Cohort 2 (Expansion): Includes newly enrolled participants randomized 1:1 to receive either NT-501 (M-CHFM) or NT-501 (CHFM). Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.

研究の種類

介入

入学 (推定)

60

段階

  • フェーズ 3

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
      • Walnut Creek、California、アメリカ、94598
        • 積極的、募集していない
        • Bay Area Retina Associates, A Medical Group
    • Michigan
      • Grand Rapids、Michigan、アメリカ、49546
        • 積極的、募集していない
        • Foundation for Vision Research
    • Texas
      • Bellaire、Texas、アメリカ、77401
        • 積極的、募集していない
        • Retina Consultants of Texas
  • オーストラリア
      • East Melbourne、オーストラリア
      • Perth、オーストラリア
        • 募集
        • Lion's Eye Institute
        • コンタクト：
        • 主任研究者：
          • Ian Constable, MD
      • Sydney、オーストラリア
        • まだ募集していません
        • Sydney Eye Hospital
        • コンタクト：
        • 主任研究者：
          • Elisa Cornish, 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

21年～80年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria

To participate in this study, the potential subject and at least 1 of their eyes must meet all of the following criteria:

  1. Subjects must have a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500-micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities seen clinically or on SD-OCT.
  2. Subject must have a break in the ellipsoid zone (EZ) (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 millimeters squared.
  3. Subject's best-corrected visual acuity (BCVA) is 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening.
  4. Subject must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality retinal imaging.
  5. Subject must be greater than or equal to 21 years of age and less than 80 years of age at screening.
  6. Subject or their legally authorized representative must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practices guidelines, and local regulations, before initiating any study-related procedures.

Exclusion Criteria

To participate in this study, the potential subject must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):

  1. Subject is medically unable to comply with study procedures or follow-up visits.
  2. Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
  3. Subject has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye OR has, within the past 3 months, received intravitreal anti-VEGF therapy in the fellow eye at randomization.
  4. Subject has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (e.g., uncontrolled glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis).
  5. Subject has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted). The exceptions to this exclusion criteria include artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
  6. Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
  7. Subject has evidence of intraretinal hyperreflectivity by OCT.
  8. Subject has evidence of central serous chorio-retinopathy in either eye.
  9. Subject has evidence of pathologic myopia in either eye.
  10. Subject has significant corneal or media opacities in either eye.
  11. Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
  12. Subject has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age -Related Eye Disease Study (AREDS) clinical lens grading system.
  13. Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
  14. Previous participation in any Neurotech MacTel clinical trial unless the participant: (1) previously consented and screened for a MacTel study but was a screen failure solely due to insufficient lesion size; or (2) has completed participation in the prior Neurotech MacTel study, is not actively enrolled in another Neurotech MacTel study, and has an eligible study eye that was not the study eye in the previous trial.
  15. Subject was a participant in any other ocular related or ocular impacted clinical trial of an intervention (drug or device) within the last 6 months.
  16. Subject is on chemotherapy.
  17. Subject is pregnant or breastfeeding.
  18. Subject has a history of malignancy that would compromise the 12-month study survival.
  19. Subject with a history of ocular herpes virus in either eye.
  20. Subject has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
  21. Subject has evidence of subfoveal RPE hyperplasia.

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：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Cohort 1 (Extension) - M-CHFM

Previously enrolled Cohort 1 participants received M-CHFM and will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason.
組み合わせ製品：M-CHFM

Single implantation of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM)
実験的：Cohort 2 (Expansion) - M-CHFM

Participants are randomized 1:1 to receive M-CHFM. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.
組み合わせ製品：M-CHFM

Single implantation of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM)
アクティブコンパレータ：Cohort 2 (Expansion) - CHFM

Participants are randomized 1:1 to receive CHFM (US commercially available ENCELTO). Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.
組み合わせ製品：CHFM

Single implantation of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM)

他の名前：
  • Encelto

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
Cohort 1 (Extension) - Efficacy
時間枠：Baseline to 24 months

Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye of NT-501 in participants who received NT-501 with M-CHFM
Baseline to 24 months
Cohort 2 (Expansion) - Efficacy
時間枠：Baseline to 12 months

Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye of NT-501 in participants who received NT-501 with M-CHFM as compared to NT-501 with CHFM
Baseline to 12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Cohort 1 (Extension) - Safety
時間枠：Baseline to 24 months

Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs)
Baseline to 24 months
Cohort 2 (Expansion) - Safety
時間枠：Baseline to 12 months

Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs)
Baseline to 12 months
Cohort 1 (Extension) - Best Corrected Visual Acuity
時間枠：Baseline to 24 months

Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart
Baseline to 24 months
Cohort 2 (Expansion) - Best Corrected Visual Acuity
時間枠：Baseline to 12 months

Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart
Baseline to 12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Cohort 1 (Extension) - Aqueous CNTF
時間枠：Month 12 - Month 24

Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration
Month 12 - Month 24
Cohort 2 (Expansion) - Aqueous CNTF
時間枠：Baseline to 12 months

Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration
Baseline to 12 months

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

Neurotech Pharmaceuticals

捜査官

  • スタディチェア：Thomas Aaberg, Jr., MD、Neurotech Pharmaceuticals

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 (実際)

2025年3月6日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2028年7月24日

試験登録日

最初に提出

2024年4月29日

QC基準を満たした最初の提出物

2024年4月29日

最初の投稿 (実際)

2024年5月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年10月30日

最終確認日

2026年10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

  • NTMT-03C

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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