Full Text View
Tabular View
Study Results
Related Studies
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
This study has been completed.
Study NCT00324116   Information provided by Pfizer
First Received: May 8, 2006   Last Updated: October 1, 2009   History of Changes

May 8, 2006
October 1, 2009
July 2006
August 2008   (final data collection date for primary outcome measure)
Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: Baseline, 54 Weeks ] [ Designated as safety issue: No ]
  • baseline less than (<) 15 letters of the best-corrected visual acuity expressed
  • Proportion of responders at 54 weeks, defined as patients having lost from
  • as an ETDRS score; this includes patients with visual acuity gain from baseline.
Complete list of historical versions of study NCT00324116 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Visual Acuity [ Time Frame: Baseline, 6 weeks, 12 weeks, 54 weeks ] [ Designated as safety issue: No ]
  • Number of Subjects Gaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
  • Number of Subjects Maintaining Vision [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
  • Number of Subjects With Severe Visual Loss [ Time Frame: 54 weeks or at early termination ] [ Designated as safety issue: No ]
  • Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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.
 
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions
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

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.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Macular Degeneration
Drug: pegaptanib sodium (Macugen)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
81
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00324116
Director, Clinical Trial Disclosure Group, Pfizer Inc
A5751016
Pfizer
ITEC GROUP 3
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

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