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Trial record 1 of 1 for:    NCT00324116
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Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

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ClinicalTrials.gov Identifier: NCT00324116
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : October 2, 2009
Last Update Posted : March 23, 2010
Sponsor:
Collaborator:
ITEC GROUP 3
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 8, 2006
First Posted Date  ICMJE May 10, 2006
Results First Submitted Date  ICMJE August 25, 2009
Results First Posted Date  ICMJE October 2, 2009
Last Update Posted Date March 23, 2010
Study Start Date  ICMJE July 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Baseline, 54 Weeks ]
Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
  • Proportion of responders at 54 weeks, defined as patients having lost from
  • baseline less than (<) 15 letters of the best-corrected visual acuity expressed
  • as an ETDRS score; this includes patients with visual acuity gain from baseline.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
  • Change From Baseline in Visual Acuity [ Time Frame: Baseline, 6 weeks, 12 weeks, 54 weeks ]
    Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline.
  • Number of Subjects Gaining Vision [ Time Frame: 54 weeks or at early termination ]
    Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
  • Number of Subjects Maintaining Vision [ Time Frame: 54 weeks or at early termination ]
    Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
  • Number of Subjects With Severe Visual Loss [ Time Frame: 54 weeks or at early termination ]
    Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0.
  • Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) [ Time Frame: 54 weeks ]
    Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54. Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54.
  • Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). [ Time Frame: Baseline, 54 weeks or at early termination ]
    Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain:4,19; Near Vision:5,6,7; Distance Vision:8,9,14; Social Functioning:11,13; Mental Health Activities:3,21,22,25; Role Difficulties:17,18; Dependency:20,23,24; Driving:15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2006)
  • Proportion of patients with severe visual loss at 54 weeks
  • (loss from baseline of more than 30 letters of visual acuity)
  • Proportion of patients maintaining vision at 54 weeks
  • (gain from baseline of more than 0 letters of visual acuity)
  • Proportion of gaining vision at 54 weeks
  • (gain from baseline of more than 15 letters of visual acuity)
  • Mean change from baseline in visual acuity at 6, 12 and 54 weeks
  • Proportion of patients progressing to a visual acuity of < ou = 20/200
  • at 54 weeks of those who had a visual acuity of > 20/200 at baseline
  • Changes from baseline in patient reported vision-related functioning
  • and quality of life as measured using the NEI-VFQ 25 at 54 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
Official Title  ICMJE A Prospective, Open-Label Multi Center Trial Evaluating The Safety And Efficacy Of 0.3 Mg/Eye Pegaptanib Sodium (Macugen) Intravitreous Injection Given Every 6 Weeks For 54 Weeks In Patients With Small Neovascular Age-Related Macular Degeneration (AMD) Lesions
Brief Summary To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE Drug: pegaptanib sodium (Macugen)
0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks.
Other Name: MACUGEN
Study Arms  ICMJE Experimental: Active
Intervention: Drug: pegaptanib sodium (Macugen)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2009)
81
Original Enrollment  ICMJE
 (submitted: May 9, 2006)
195
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
  • Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
  • Women must be using 2 forms of effective contraception
  • Adequate hematological, renal and liver functions

Exclusion Criteria:

  • Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
  • Any extrafoveal choroidal neovascularization
  • Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
  • Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
  • Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324116
Other Study ID Numbers  ICMJE A5751016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE ITEC GROUP 3
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP