개입 없음의 황반 변성 및 혈관 내피 성장 인자 - 임상 시험 레지스트리

연구 개요

상태

종료됨

정황

개입 / 치료

다른: 개입 없음

상세 설명

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.

연구 유형

관찰

등록 (실제)

22

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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).

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA) 기간: 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 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

To obtain contact information for a study center near you, click here.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 11월 1일

기본 완료 (실제)

2010년 8월 1일

연구 완료 (실제)

2010년 8월 1일

연구 등록 날짜

최초 제출

2008년 8월 14일

QC 기준을 충족하는 최초 제출