Comparison of VA Guided Versus OCT Guided TER Using Aflibercept for Diabetic Macular Edema (AVOCT Study) (AVOCT)
2021年3月15日 更新者:University Hospital Inselspital, Berne
A Randomized, Study Investigating the Efficacy of Visual Acuity-based Versus Optical Coherence Tomography (OCT) -Based Treat and Extend Regimen Using Aflibercept in Patients With Diabetic Macular Edema
This study will evaluate the effectiveness of aflibercept (Eylea®) using two different treatment protocols in patients with vision loss from diabetic macular edema.
While one group will be treated with an optical coherence tomography (OCT) guided 'treat and extend' regimen, the other group will be treated according to a visual acuity (VA) guided 'treat and extend' protocol.
The patients will be randomized into two treatment arms using an automated randomization algorithm.
調査の概要
詳細な説明
For the study arm receiving the VA-guided treatment regimen, the following retreatment criteria will be applied:
- if visual acuity remains stable (± 5 ETDRS letters) treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if visual acuity decreases by more than 5 ETDRS letters treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
For the study arm receiving the OCT-guided treatment regimen, the following retreatment criteria will be applied:
- if SD-OCT examinations show 1) no SRF in any area of the OCT scan present and 2) no IRF, treatment intervals will be extended by 2 weeks as compared to the previous retreatment interval.
- if SD-OCT examinations show 1) any SRF present in any area of the OCT scan and/or 2) any IRF present, treatment intervals will be shortened by 1 week as compared to the previous retreatment interval, whereby retreatment intervals cannot be shorter than 28 days (4 weeks). Once treatment intervals have been shortened, the patient should be seen at two consecutive visits with no diabetic retinopathy disease activity before re-extending the treatment interval.
研究の種類
観察的
入学 (実際)
110
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。
研究場所
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Bern、スイス、3010
- Inselspital Bern, Department of Ophthalmology
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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
18年歳以上 (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
サンプリング方法
非確率サンプル
調査対象母集団
Patients with vision loss due to diabetic macular edema
説明
General:
- Informed consent as documented by signature of the patient on the informed consent form.
- Male or female, ≥ 18 years of age.
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- No relevant change in medication for the management of diabetes within 3 months prior to randomization.
- Patients fulfilling criteria specified in the respective SmPC for aflibercept for the treatment of DME
Study eye:
- Visual impairment due to focal or diffuse DME in at least one eye. If both eyes are eligible, the eye with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
- BCVA score between 78 and 39 letters using ETDRS- visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) Decrease in vision and CRT due to DME and not due to other causes, at the investigators discretion
Inclusion criteria:
General:
- Informed consent as documented by signature of the patient on the informed consent form.
- Male or female, ≥ 18 years of age.
- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
- No relevant change in medication for the management of diabetes within 3 months prior to randomization.
- Patients fulfilling criteria specified in the respective SmPC for aflibercept for the treatment of DME
Study eye:
- Visual impairment due to focal or diffuse DME in at least one eye. If both eyes are eligible, the eye with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
- BCVA score between 78 and 39 letters using ETDRS- visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) Decrease in vision and CRT due to DME and not due to other causes, at the investigators discretion
Exclusion criteria:
General:
- Inability to comply with study or follow-up procedures.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases.(Female participants who are surgically sterilised/ hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)
- Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree.
- Stroke or myocardial infarction less than 3 months prior to the date of informed consent signature.
- Known hypersensitivity to aflibercept or any component of the aflibercept formulation. Any other reason that would prevent treatment with aflibercept specified in the SmPC
- Current use of any systemic anti- VEGF drugs [e.g., bevacizumab (Avastin®)].
- Use of other investigational drugs at screening visit.
Both eyes:
- Any active ocular infection or inflammation (scleritis, uveitis, endophthalmitis) at the time of screening or baseline.
- Uncontrolled glaucoma [intraocular pressure (IOP) ≥30 mmHg on medication or according to Investigator's judgment] at the time of screening or baseline.
- Neovascularisation of the iris or neovascular glaucoma at the time of screening or baseline.
- Intravitreal corticosteroids administered within 3 months prior to the date of informed consent signature.
Study eye:
- Visually significant cataract, vitreous hemorrhage, rhegmatogenous retinal detachment or age related macular degeneration
- Intraocular treatment with any anti-VEGF drug or intravitreal corticosteroids prior to the date of informed consent signature.
- Inability of obtaining SD-OCT images of sufficient quality to be analysed
- Any intraocular procedure anticipated within the next 6 months following the date of informed consent signature
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
コホートと介入
グループ/コホート |
介入・治療 |
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OCT guided treatment arm
OCT guided aflibercept injection
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Intravitreal injection of Aflibercept for DME OCT guided
他の名前:
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VA guided treatment arm
VA guided aflibercept injection
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Intravitreal injection of Aflibercept for DME VA guided
他の名前:
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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 |
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Functional outcomes
時間枠:24 months
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Mean change in BCVA from baseline to week 104 (EOS)
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24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of visits
時間枠:24 months
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Number of visits per Treatment arm
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24 months
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Number of injections
時間枠:24 months
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Number of injections per Treatment arm
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24 months
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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。
捜査官
- スタディディレクター:Martin Zinkernagel, MD, PhD、University of Bern, Switzerland
- 主任研究者:Marion Munk, MD, PhD、University of Bern, Switzerland
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)
2017年9月16日
一次修了 (実際)
2021年2月1日
研究の完了 (実際)
2021年2月1日
試験登録日
最初に提出
2016年1月4日
QC基準を満たした最初の提出物
2018年1月8日
最初の投稿 (実際)
2018年1月9日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月18日
QC基準を満たした最後の更新が送信されました
2021年3月15日
最終確認日
2021年3月1日
詳しくは
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。
OCT guided treatment armの臨床試験
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