A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
調査の概要
状態
介入・治療
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究連絡先のバックアップ
- 名前：Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.
- 電話番号：888-662-6728 (U.S. and Canada)
- メール：global-roche-genentech-trials@gene.com
研究場所
-
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California
-
Walnut Creek、California、アメリカ、94598-5915
- 募集
- Bay Area Retina Specialists Medical Group - Vestrum - PPDS
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27103-6945
- 募集
- Piedmont Retina Specialists
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Pennsylvania
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Erie、Pennsylvania、アメリカ、16505
- 募集
- Erie Retina Research
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Texas
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Arlington、Texas、アメリカ、76012-2505
- 募集
- Texas Retina Associates - Arlington
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Virginia
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Lynchburg、Virginia、アメリカ、24502-4271
- 募集
- Piedmont Eye Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Ocular Inclusion Criteria for the Study Eye
- BCVA score of >= 35 letters using the ETDRS VA chart at a starting distance of 4 meters
- Lesions may be either extrafoveal or subfoveal
Ocular Inclusion Criteria for Both Eyes
- Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
- Well-demarcated GA secondary to AMD
Exclusion Criteria:
General Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection
Ocular Exclusion Criteria for the Study Eye
- History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy
- Current or prior history of central serous retinopathy
- Aphakia or absence of the posterior capsule in the study eye
Ocular Exclusion Criteria for the Non-Study Eye
- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)
Ocular Exclusion Criteria for Either Eye
- Proliferative diabetic retinopathy
- History of recurrent infectious or inflammatory ocular disease
- Current or prior history of choroidal neovascularization (CNV) in either eye
- Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Other protocol-defined inclusion/exclusion criteria may apply
研究計画
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：ダブル
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：Placebo
Participants will receive placebo. |
Placebo will be administered as per the schedule defined in the protocol. |
|
実験的：RO7965032 Dose Level 1
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
|
実験的：RO7965032 Dose Level 2
Participants will receive RO7965032. |
RO7965032 will be administered as per the schedule defined in the protocol. |
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 |
時間枠 |
|---|---|
|
Change of GA Lesion Area in the Study Eye
時間枠：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Ocular Adverse Events (AEs)
時間枠：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Incidence and Severity of Non-Ocular AEs
時間枠：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change of GA Lesion Area in the Study Eye
時間枠：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
|
Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
時間枠：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
時間枠：Baseline up to approximately 48 weeks
|
Baseline up to approximately 48 weeks
|
|
Incidence and Severity of Selected Findings in Ocular Examinations and Ocular Imaging
時間枠：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
|
Plasma Concentration of RO7965032
時間枠：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
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Percent Change from Baseline in Levels of Target Protein in Plasma
時間枠：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
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Percent Change from Baseline in Levels of Plasma Biomarker Activity
時間枠：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
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Prevalence and Incidence of Anti-Drug Antibodies (ADAs)
時間枠：Baseline up to approximately 72 weeks
|
Baseline up to approximately 72 weeks
|
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Recommended Dose of RO7965032
時間枠：Up to approximately 72 Weeks
|
Up to approximately 72 Weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- XR46785
- 2026-527027-10-00 (Ctis)
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?
IPD プランの説明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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
米国FDA規制機器製品の研究
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。