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Macugen Observational Study

2011年8月26日 更新者：Pfizer
The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.

If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.

The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.

研究の種類

観察的

入学 (実際)

22

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

  • インド
    • Gujarat
      • Navrangpura, Ahemdabad、Gujarat、インド、380009
        • Pfizer Investigational Site
    • Haryana
      • Gurgaon、Haryana、インド、122 002
        • Pfizer Investigational Site
    • Kerala
      • Cochin、Kerala、インド、682 015
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai、Maharashtra、インド、400 054
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur、Rajasthan、インド、302 004
        • Pfizer Investigational Site

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～90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

サンプリング方法

非確率サンプル

調査対象母集団

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

説明

Inclusion Criteria:

  • To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).

Exclusion Criteria:

  • Active or suspected ocular or periocular infection.
  • Known hypersensitivity to pegaptanib sodium or any other excipient in this product.

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

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
Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)
時間枠：Baseline through 12 months or last follow-up visit before study termination
VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.
Baseline through 12 months or last follow-up visit before study termination
Average Number of Injections to Achieve Stabilization of VA
時間枠：12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
12 months or last follow-up visit before study termination
Median Number of Injections to Achieve Stabilization of VA
時間枠：12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
12 months or last follow-up visit before study termination

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy
時間枠：12 months or last follow-up visit before study termination
Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.
12 months or last follow-up visit before study termination
Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters
時間枠：12 months or last follow-up visit before study termination
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).
12 months or last follow-up visit before study termination
Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters
時間枠：12 months or last follow-up visit before study termination
A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.
12 months or last follow-up visit before study termination
Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA
時間枠：12 months or last follow-up visit before study termination
Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.
12 months or last follow-up visit before study termination
Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
時間枠：12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
12 months or last follow-up visit before study termination
Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions
時間枠：12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
12 months or last follow-up visit before study termination
Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA
時間枠：12 months or last follow-up visit before study termination
FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.
12 months or last follow-up visit before study termination
Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen
時間枠：12 months or last follow-up visit before study termination
Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.
12 months or last follow-up visit before study termination
Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy
時間枠：12 months or last follow-up visit before study termination
VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient's VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.
12 months or last follow-up visit before study termination
Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy
時間枠：12 months or last follow-up visit before study termination
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.
12 months or last follow-up visit before study termination
Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive
時間枠：12 months or last follow-up visit before study termination
OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.
12 months or last follow-up visit before study termination

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

Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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

2008年11月1日

一次修了 (実際)

2010年8月1日

研究の完了 (実際)

2010年8月1日

試験登録日

最初に提出

2008年8月14日

QC基準を満たした最初の提出物

2008年8月14日

最初の投稿 (見積もり)

2008年8月15日

学習記録の更新

投稿された最後の更新 (見積もり)

2011年8月29日

QC基準を満たした最後の更新が送信されました

2011年8月26日

最終確認日

2011年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A5751031

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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