Natural History Study of Advanced RCD (ECSTASI)
External Control, preScreening, and naTurAl hiStory of Advanced retInal Degeneration Due to Rod-cone Dystrophy (ECSTASI)
ECSTASI is a Natural History Study, which will be monitoring how standard of care (SoC) affect advanced rod-cone dystrophy (RCD), a type of eye disease also known as retinitis pigmentosa. No experimental, investigational or any other drug or treatment will be tested during the study.
This study collects information in 3 parts:
Part 1: retrospective health information from medical records (up to past 10 years), Part 2: prospective health information from in-person visits (up to 1 year), and Part 3: prospective health information from medical records (up to 1 year). Participants will decide if they wish to participate in all or only to some of these parts.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Medical Director
研究連絡先のバックアップ
- 名前：SparingVision
- 電話番号：+33143462060
- メール：info@sparingvision.com
研究場所
-
-
-
Dublin、アイルランド
- まだ募集していません
- Royal Victoria Eye And Ear Hospital
-
コンタクト：
- 電話番号：00 353 1 664 4600
- メール：Emma.duignan@rveeh.ie
-
主任研究者：
- Emma Duignan, Dr
-
-
-
-
-
Paris、フランス
- まだ募集していません
- CHNO XV-XX Paris - CIC 1423
-
コンタクト：
- Isabelle Audo, Prof.
- 電話番号：00 33 1 40 02 14 57
- メール：isabelle.audo@inserm.fr
-
主任研究者：
- Isabelle Audo, Dr
-
-
-
-
-
Ghent、ベルギー
- 募集
- Ghent University Hospital
-
コンタクト：
- Ophthalmic Clinical Trials Unit
- メール：OCTU@uzgent.be
-
主任研究者：
- Bart Leroy, Prof
-
-
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:
- Males and females 18 years of age or older, with history of formed vision
- Clinical diagnosis of advanced retinal degeneration due to RCD
- BCVA no better than (≥) 1.0 LogMAR (≤35 Early-Treatment Diabetic Retinopathy Study [ETDRS] letters, or 20/200 Snellen equivalent) in at least one eye
- Documented preservation of foveal Outer Nuclear Layer (ONL) in at least one eye
Exclusion Criteria:
- Individuals who are receiving or have received an investigational medicinal product (IMP) in another clinical trial are excluded from the prospective part . However, they can participate in the retrospective part of the study.
- Individuals with a medical condition (systemic or ophthalmic), psychiatric condition (including substance abuse disorder), physical examination or laboratory findings that may in the opinion of the Investigator preclude adherence to the scheduled study visits, safe participation in the study, or affect study results are excluded from participating in in-person study visits. However, they can participate in the collection of data reported during both retrospective and prospective SoC routine eye examinations.
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：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Prospective and/or retrospective data collection
This Natural History study is designed as a combination of prospective and retrospective evaluations in patients diagnosed with advanced RCD. Prospective data will be collected during in-person study visits and/or SoC routine eye examinations (not planned per protocol) as they are reported in the medical records of the participant for up to 1 year after study enrollment. Retrospective data will be collected from the medical records of the participant for up to 10 years before enrollment. |
Routine eye examinations (including slit lamp exam and dilated fundus exam), standard visual assessments (such as best corrected visual acuity test and ocular coherence tomography), evaluation of visual function (such as microperimetry). Patient-reported quality of life questionnaire. |
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 |
|---|---|---|
|
Best-corrected visual acuity (BCVA)
時間枠：At 6 months
|
Change in BCVA from Baseline to Month 6 |
At 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the effects of SoC on visual function at 1 year of follow up
時間枠：At 1 year
|
Change in BCVA from baseline to Year 1 |
At 1 year
|
|
To determine the precision and reliability of the assessments of visual function measured in ECSTASI
時間枠：1 year
|
Test-retest variability and signal-to-noise ratio of visual function measurements such as BCVA and microperimetry. |
1 year
|
|
To evaluate participant potential eligibility for the Phase 1/2a clinical trial of SPVN20 (NYRVANA).
時間枠：1 year
|
Percentage of participants potentially eligible to participate in the Phase 1/2a clinical trial of SPVN20 (NYRVANA), based on data collected in the ECSTASI study. |
1 year
|
|
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for FST
時間枠：1 year
|
Change in FST from baseline to Month 6 and Year 1 |
1 year
|
|
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for microperimetry
時間枠：1 year
|
Change in microperimetry foveal sensitivity from baseline to Month 6 and Year 1 |
1 year
|
|
To evaluate the effects of SOC on visual function at 6 months and 1 year of follow-up for eye dominance
時間枠：1 year
|
Change in eye dominance from baseline to Month 6 and Year 1 |
1 year
|
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- SPVN-NHS-03
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?
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。