A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study) (iDEAL)
2017年7月28日 更新者：Johns Hopkins University
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema With Involvement of the FoveAL Center (the iDEAL Study)
- To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
- To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12
調査の概要
状態
終了しました
条件
研究の種類
介入
入学 (実際)
185
段階
- フェーズ2
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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Nebraska
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Omaha、Nebraska、アメリカ、68198-5540
- Stanley M Truhlsen Eye Institute
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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
説明
Inclusion Criteria:
- Age ≥18 years
- Have diabetes mellitus type I or II (insulin or non-insulin dependent) with HbA1c ≥5.5% and HbA1c ≤13%; have non-proliferative diabetic retinopathy, or inactive proliferative diabetic retinopathy, or proliferative diabetic retinopathy with a reasonable expectation that panretinal photocoagulation will not be required during the study follow-up period
- Have diabetic macular edema with central subfield thickness of ≥250 microns (confirmed by Stratus Time-Domain(TD) OCT
Have best corrected visual acuity (ETDRS) that is Snellen equivalent of
- 20/32 and ≥20/320, inclusive
- Be willing and able to sign an approved written informed consent. If a patient has a central nervous system disorder (i.e. dementia) that will not allow him/her to understand the consent independently, the patient will not be allowed to join the study
- Be able to attend all scheduled study visits
- Women who are not lactating or pregnant and are willing to use adequate contraception during the study period, if appropriate
Exclusion Criteria:
- Have macular or perimacular edema secondary to an etiology other than diabetes
- Have concurrent retinal diseases other than diabetic retinopathy
- Have additional ocular diseases compromising visual acuity and/or interfering with study assessments; patients who have glaucoma but deemed stable (intraocular pressure ≤ 25 mmHg at screening) on medications or status post surgery, may participate in the study
- Participant has a history of prior pars plana vitrectomy
- Subjects with significant cataract or or posterior capsular opacification that may need intervention within one year or vitreous opacity that hinder study assessment (i.e.fundus examination) which requires intervention within a year
- Subjects who have DME with severe capillary non-perfusion (avascular zone diameter >1,000 microns)
- Have an allergy to fluorescein dye
- Have terminal renal disease (on active kidney dialysis), cerebral vascular accident(including TIA), myocardial infarction or congestive heart disease within 6 months of study enrollment, liver damage (2x upper limit of normal range for aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or total bilirubin). Patients who may have received renal transplant in the past and now have stable renal function, may participate in the study
- Subjects with systolic blood pressure higher than 180 mm Hg or diastolic above 100 mm Hg, with or without anti-hypertensive treatment
- Have a history of panretinal photocoagulation (PRP) in the study eye within 3 months of study entry or are likely to have PRP in the study eye during study participation
- Had macular photocoagulation or ocular surgery within 3 months of study entry in the study eye
- Received intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry or anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, VEGF-TRAP, protein kinase C inhibitor, etc.) within 2 months of study entry; history of usage of topical or systemic steroids within 3 months of study entry is not an exclusion
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：階乗代入
- 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 |
|---|---|
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実験的：Group 1
Drug: iCo-007 350 mcg iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 |
iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
他の名前：
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実験的：Group 2
Drug: iCo-007 700 mcg iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 |
iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
他の名前：
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実験的：Group 3
Drug: iCo-007 350 mcg and Laser iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation |
iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation.
At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment.
If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
他の名前：
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実験的：Group 4
Drug: Ranibizumab and iCo-007 350 mcg Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later |
Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
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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Change in VA From Baseline to Month 8
時間枠：Baseline to month 8
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The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
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Baseline to month 8
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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 |
|---|---|---|
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Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability
時間枠：Baseline to month 8
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Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation.
Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;
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Baseline to month 8
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Change in VA From Baseline to Month 12
時間枠：Baseline to month 12
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The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12
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Baseline to month 12
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Change in Retinal Thickness Measured by OCT From Baseline to Month 8
時間枠：Baseline to month 8
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Group 1
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Baseline to month 8
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Change in Retinal Thickness Measured
時間枠：Baseline to month 12
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measured by OCT
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Baseline to month 12
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Duration of iCo-007 Treatment Effect
時間枠：Baseline to month 12
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treatment effect as measured by VA and OCY thickness
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Baseline to month 12
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Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections
時間枠：Baseline to month 12
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cmax
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Baseline to month 12
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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。
スポンサー
捜査官
- 主任研究者：Diana V. Do, MD、Stanley M Truhlsen Eye Institute, University of Nebraska Medical Center
- 主任研究者：Robert Wong, MD、Austin Retina Associates
- 主任研究者：Michael J. Tolentino, MD、Center for Retina Macula Disease
- 主任研究者：Prema Abraham, MD、Black Hills Regional Eye Institute
- 主任研究者：Eugene Lit, MD、East Bay Retina Institute
- 主任研究者：Michael J. Elman, MD、Elman Retina Group
- 主任研究者：Thomas A. Barnard, MD、Florida Retina Institute
- 主任研究者：Thomas A. Ciulla, MD、Midwest Eye Institute
- 主任研究者：Richard B. Rosen, MD、New York Eye and Ear Infirmary
- 主任研究者：Henry L. Hudson, MD、Retina Centers, P.C.
- 主任研究者：Pravin Dugel, MD、Retina Consultants of Arizona
- 主任研究者：Gregg T. Kokame, MD、Retina Consultants of Hawaii, Pali Momi Medical Center
- 主任研究者：David M. Brown, MD、Retina Consultants Houston
- 主任研究者：Larry S. Halperin, MD、Retina Group of Florida
- 主任研究者：Goergios Papastergio, MD、Retina Institute of Hawaii
- 主任研究者：Ron P. Gallemore, MD. PhD、Retina Macula Institute
- 主任研究者：Brian B. Berger, MD、Retina Research Center
- 主任研究者：Homayoun Tabandeh, MD、Retina Vitreous Associates
- 主任研究者：Dennis M. Marcus, MD、Southeast Retina
- 主任研究者：Robert S. Wirthlin, MD、Spokane Eye Clinic
- 主任研究者：David Callanan, MD、Texas Retina Associates in Arlington
- 主任研究者：Karl G. Csaky, MD, PhD、Texas Retina Associates in Dallas
- 主任研究者：Surendar Purohit, MD、TLC Eye Care & Laser Center
- 主任研究者：Victor H. Gonzalez, MD、Valley Retina Institute
- 主任研究者：Louis Glazer, MD、Vitreo-Retinal Associates
- 主任研究者：Dean Eliott, MD、Massachusetts Eye and Ear Infirmary, Harvard Medical School
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)
2012年2月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年10月1日
試験登録日
最初に提出
2012年3月15日
QC基準を満たした最初の提出物
2012年3月26日
最初の投稿 (見積もり)
2012年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2017年8月30日
QC基準を満たした最後の更新が送信されました
2017年7月28日
最終確認日
2017年7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。